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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`12/720,482
`
`03/09/2010
`
`Shigeki JOKO
`
`28951.5423 C1
`
`9159
`
`STEPTOE & JOHNSON LLP
`1330 CONNECTICUT AVE., NW
`WASHINGTON, DC 20036
`
`SISSON, BRADLEY L
`
`ART UNIT
`
`1634
`
`PAPER NUIVIBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/12/2015
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`ipdocketing @ steptoe.c0m
`hfox @ steptoe.c0m
`lfielding @ steptoe.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 12/720,482 JOKO, SHIGEKI
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1634Bradley L. Sisson it?“
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1 .704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 01/05/2015& 03/04/2015.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:l This action is non-final.
`2a)|Z| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
`
`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI CIaim(s)1is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|Z| CIaim(s)_1is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`hit
`:17twvvausnto. ovI’ atentS/init events/
`
`
`
`hI/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 03/04/2015 is/are: a)IXI accepted or b)|:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.IZI Certified copies of the priority documents have been received in Application No. 10/554,495.
`3.|:| Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150505
`
`

`

`Application/Control Number: 12/720,482
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`Page 2
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`Art Unit: 1634
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`DETAILED ACTION
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`Notice of Pre-AIA 0r AIA Status
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`1.
`
`The present application is being examined under the pre—AIA first to invent provisions.
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`2.
`
`The drawings were received on March 4th, 2015. These drawings are acceptable.
`
`Drawings
`
`Claim Rejections - 35 USC § 112
`
`3.
`
`The following is a quotation of 35 USC. 112(b):
`
`(b) CONCLUSION.7The specification shall conclude with one or more claims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 USC. 112 (pre—AIA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`4.
`
`Claim 1 is rejected under 35 USC. 112(b) or 35 USC. 112 (pre—AIA), second
`
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
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`matter which the inventor or a joint inventor, or for pre—AIA the applicant regards as the
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`invention.
`
`5.
`
`As a result of amendment, claim 1 is deemed to be confusing for it now recites in the first
`
`step: “adding a nucleotide sequence containing hypoxanthine to the 3’—terminal of a nucleic acid
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`target for modification select from the group consisting of a DNA, RNA, and oligonucleotide.”
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`

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`Application/Control Number: 12/720,482
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`Page 3
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`Art Unit: 1634
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`(Emphasis added) As presently worded, it appears that the “modification,” not the “nucleotide
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`sequence,” is “selected from the group consisting of a DNA, RNA, and oligonucleotide.”
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`6.
`
`Claim 1 is deemed to be indefinite with respect to what constitutes the metes and bounds
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`of an “oligonucleotide.”
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`7.
`
`A review of the disclosure fails to find where applicant has provided a closed definition
`
`for the term “oligonucleotide,” and a review of the art finds that there is not a single art—accepted
`
`definition. In support of this position, it is noted that US Patent 6,444,650 B1 (Chech et al.), at
`
`column 4, states:
`
`As used herein "oligonucleotides" or "oligomers" refer to a nucleic acid sequence of
`approximately 7 nucleotides or greater in length and up to as many as approximately 100
`nucleotides in length which can be used as a primer, probe or amplimer. Oligonucleotides
`are often between about 10 and about 50 nucleotides in length more often between about
`14 and about 35 nucleotides, very often between about 15 and about 30 nucleotides, and
`the terms Oligonucleotides or oligomers can also refer to synthetic and/or non—naturally
`occurring nucleic acids (i.e., comprising nucleic acid analogies or modified backbone
`residues or linkages).
`
`In comparison, US Patent 6,444,661 B1 (Barton et a1.), column 6, first paragraph, states:
`
`The probe oligonucleotide can be as short as about 8—10 bases, up to a length of several
`thousand bases: the probe can be as long or longer than the target polynucleotide.
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`When as here it is evident that there is not a single art—accepted meaning for the term, a question
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`as to the metes and bounds of the claim exist.
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`Claim Rejections - 35 USC § 101 (Utility) & 112 (Enablement)
`
`8.
`
`35 USC. 101 reads as follows:
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or
`any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and
`requirements of this title.
`
`

`

`Application/Control Number: 12/720,482
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`Page 4
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`Art Unit: 1634
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`The following is a quotation of 35 U.S.C. 112(a):
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`(a) IN GENERAL.7The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any
`person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use
`the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying
`out the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre—AIA), first paragraph:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
`
`10.
`
`Claim 1 remains rejected under 35 U.S.C. 101 because the claimed invention is not
`
`supported by either a specific, substantial, and credible asserted utility or a well—established
`
`utility. Attention is directed to MPEP 2107.02 [R—11.2013], which states in part:
`
`The claimed invention is the focus of the assessment of whether an applicant has satisfied
`the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated
`on its own merits for compliance with all statutory requirements... Only Where it can be
`established that other species clearly encompassed by the claim do not have utility
`should a rejection be imposed on the generic claim. In such cases, the applicant should
`be encouraged to amend the generic claim so as to exclude the species that lack utility.
`(Emphasis added)
`
`Office personnel should also be especially careful not to read into a claim unclaimed
`results, limitations or embodiments of an invention. See Carl Zeiss Stifiung v. Renishaw
`PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, 292 F.2d 948,
`
`130 USPQ 215 (CCPA 1961). Doing so can inappropriately change the relationship of an
`asserted utility to the claimed invention and raise issues not relevant to examination of
`that claim.
`
`11.
`
`Attention is also directed to MPEP 2107.01 [R—11.2013], which states in part:
`
`A. Specific Utility
`A “specific utility” is specific to the subject matter claimed and can “provide a well—
`defined and particular benefit to the public.” In re Fisher, 421 F.3d 1365, 1371, 76
`USPQ2d 1225, 1230 (Fed. Cir. 2005). This contrasts with a general utility that would be
`applicable to the broad class of the invention. Office personnel should distinguish
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`

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`Application/Control Number: 12/720,482
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`Page 5
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`Art Unit: 1634
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`between situations where an applicant has disclosed a specific use for or application of
`the invention and situations where the applicant merely indicates that the invention may
`prove useful without identifying with specificity why it is considered useful. For
`example, indicating that a compound may be useful in treating unspecified disorders, or
`that the compound has “usefill biological” properties, would not be sufficient to define a
`specific utility for the compound. See, e.g., In re Kirk, 376 F.2d 936, 153 USPQ 48
`(CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967). Similarly, a claim
`to a polynucleotide whose use is disclosed simply as a “gene probe” or “chromosome
`marker” would not be considered to be specific in the absence of a disclosure of a
`specific DNA target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232 (“Any EST
`[expressed sequence tag] transcribed from any gene in the maize genome has the
`potential to perform any one of the alleged uses. . .. Nothing about [applicant’s] seven
`alleged uses set the five claimed ESTs apart from the more than 32,000 ESTs disclosed in
`the [ ] application or indeed from any EST derived from any organism. Accordingly, we
`conclude that [applicant] has only disclosed general uses for its claimed ESTs, not
`specific ones that satisfy § 101.”). A general statement of diagnostic utility, such as
`diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of
`what condition can be diagnosed. Contrast the situation where an applicant discloses a
`specific biological activity and reasonably correlates that activity to a disease condition.
`Assertions falling within the latter category are sufficient to identify a specific utility for
`the invention. Assertions that fall in the former category are insufficient to define a
`specific utility for the invention, especially if the assertion takes the form of a general
`statement that makes it clear that a “useful” invention may arise from what has been
`disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA
`1973).
`
`B. Substantial Utility
`“[A]n application must show that an invention is useful to the public as disclosed in its
`current form, not that it may prove useful at some future date after further research.
`Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that
`the claimed invention has a significant and presently available benefit to the public.”
`Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at issue in Fisher were directed
`to expressed sequence tags (ESTs), which are short nucleotide sequences that can be used
`to discover what genes and downstream proteins are expressed in a cell. The court held
`that “the claimed ESTs can be used only to gain filrther information about the underlying
`genes and the proteins encoded for by those genes. The claimed ESTs themselves are not
`an end of [applicant’s] research effort, but only tools to be used along the way in the
`search for a practical utility. . .. [Applicant] does not identify the fianction for the
`underlying protein—encoding genes. Absent such identification, we hold that the claimed
`ESTs have not been researched and understood to the point of providing an immediate,
`well—defined, real world benefit to the public meriting the grant of a patent.” Id. at 1376,
`76 USPQ2d at 1233—34). Thus a “substantial utility” defines a “real world” use. Utilities
`that require or constitute carrying out further research to identify or reasonably confirm a
`“real world” context of use are not substantial utilities. For example, both a therapeutic
`
`

`

`Application/Control Number: 12/720,482
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`Page 6
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`Art Unit: 1634
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`method of treating a known or newly discovered disease and an assay method for
`identifying compounds that themselves have a “substantial utility” define a “real world”
`context of use. An assay that measures the presence of a material which has a stated
`correlation to a predisposition to the onset of a particular disease condition would also
`define a “real world” context of use in identifying potential candidates for preventive
`measures or further monitoring. On the other hand, the following are examples of
`situations that require or constitute carrying out further research to identify or reasonably
`confirm a “real world” context of use and, therefore, do not define “substantial utilities”:
`
`(A) Basic research such as studying the properties of the claimed product itself or
`the mechanisms in which the material is involved;
`
`(B) A method of treating an unspecified disease or condition;
`(C) A method of assaying for or identifying a material that itself has no specific
`and/or substantial utility;
`(D) A method of making a material that itself has no specific, substantial, and
`credible utility; and
`(E) A claim to an intermediate product for use in making a final product that has
`no specific, substantial and credible utility.
`Office personnel must be careful not to interpret the phrase “immediate benefit to the
`public” or similar formulations in other cases to mean that products or services based on
`the claimed invention must be “currently available” to the public in order to satisfy the
`utility requirement. See, e.g., Brenner v. Manson, 383 US. 519, 534—35, 148 USPQ 689,
`695 (1966). Rather, any reasonable use that an applicant has identified for the invention
`that can be viewed as providing a public benefit should be accepted as sufficient, at least
`with regard to defining a “substantial” utility.
`
`C. Research Tools
`
`Some confusion can result when one attempts to label certain types of inventions as not
`being capable of having a specific and substantial utility based on the setting in which the
`invention is to be used. One example is inventions to be used in a research or laboratory
`setting. Many research tools such as gas chromatographs, screening assays, and
`nucleotide sequencing techniques have a clear, specific and unquestionable utility (e.g.,
`they are useful in analyzing compounds). An assessment that focuses on whether an
`invention is useful only in a research setting thus does not address whether the invention
`is in fact “useful” in a patent sense. Instead, Office personnel must distinguish between
`inventions that have a specifically identified substantial utility and inventions whose
`asserted utility requires further research to identify or reasonably confirm. Labels such as
`“research tool,” “intermediate” or “for research purposes” are not helpful in determining
`if an applicant has identified a specific and substantial utility for the invention.
`
`12.
`
`As presently worded, claim 1 is drawn to “[a] method for modifying a nucleic acid.”
`
`13.
`
`The claim does not require that the nucleic acid to ultimately be modified be known at the
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`time of filing, much less require that it be useful under 35 USC 101. Brenner, C0mr. Pats. v.
`
`

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`Application/Control Number: 12/720,482
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`Page 7
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`Art Unit: 1634
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`Manson, 148 USPQ 689 (US. 1966). The case at hand is deemed to be analogous to that set
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`forth in MPEP 2107.01 B (D), supra, which teaches that “[a] method of making a material that
`
`itself has no specific, substantial, and credible utility” is not considered to have a substantial
`
`utility.
`
`14. While nucleic acids, which satisfy the utility requirements of 35 USC 101, were known at
`
`the time of filing, such narrowing limitations have not been read into the claims. See MPEP
`
`2111.01 and Superguide.
`
`15.
`
`Applicant is urged to consider amending the claims such that the claims are drawn to
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`those nucleic acids that unquestionably do have utility under 35 USC 101 and which are
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`adequately supported by the original disclosure.
`
`16.
`
`Claim 1 also remains rejected under 35 USC. 112(a) or 35 USC. 112 (pre—AIA), first
`
`paragraph, as failing to comply with the enablement requirement. Specifically, since the claimed
`
`invention is not supported by either a specific, substantial, and credible asserted utility or a well—
`
`established utility for the reasons set forth above, one skilled in the art clearly would not know
`
`how to use the claimed invention.
`
`Response to Argument
`
`17.
`
`Applicant’s representative, at pag3 7 of the response of January 5, 2015, hereinafter the
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`response, asserts:
`
`The claimed method for modifying a nucleic acid has utility, because a nucleic acid can
`be directly modified to label or conjugate the nucleic acid, and the nucleic acid is
`completely conserved without being decomposed and without incorporation of any
`unnecessary nucleotide chain. The product of the claimed method is a modified nucleic
`acid which is useful as a detection probe or a target in gene analysis. See applicant's
`specification, page 18, lines 6—7. (Emphasis added)
`
`

`

`Application/Control Number: 12/720,482
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`Page 8
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`Art Unit: 1634
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`18.
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`The above argument has been considered and has not been found to persuasive. As
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`reproduced above, MPEP 2107.01 A, "a claim to a polynucleotide whose use is disclosed simply
`
`as a “gene probe” or “chromosome marker” would not be considered to be specific in the
`
`absence of a disclosure of a specific DNA target.” Additionally, as set forth in MPEP 2107 B:
`
`“A method of making a material that itself has no specific, substantial, and credible utility” is not
`
`considered to satisfy the substantial utility requirement. While useful sequences were known at
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`the time of filing, such narrowing limitations cannot be read into the claims when the claim is
`
`broader than those narrowing limitations. In support of this position, attention is directed to
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`MPEP 2111.01 [R—11.2013], wherein is stated:
`
`II.
`
`IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE
`
`SPECIFICATION
`
`“Though understanding the claim language may be aided by explanations contained in
`the written description, it is important not to import into a claim limitations that are not
`part of the claim. For example, a particular embodiment appearing in the written
`description may not be read into a claim when the claim language is broader than the
`embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69
`USPQ2d 1865, 1868 (Fed. Cir. 2004).
`
`Claim Rejections - 35 USC § 112
`
`19.
`
`The following is a quotation of the first paragraph of 35 USC. 112(a):
`
`(a) IN GENERAL.7The specification shall contain a written description of the invention,
`and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to
`make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor
`of carrying out the invention.
`
`20.
`
`The following is a quotation of the first paragraph of pre—AIA 35 USC. 112:
`
`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`
`

`

`Application/Control Number: 12/720,482
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`Page 9
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`Art Unit: 1634
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`skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
`
`21.
`
`Claim 1 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre—AIA), first
`
`paragraph, as failing to comply with the written description requirement. The claim(s) contains
`
`subject matter which was not described in the specification in such a way as to reasonably
`
`convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre—AIA the
`
`inventor(s), at the time the application was filed, had possession of the claimed invention.
`
`22.
`
`As set forth in In re Alonso 88 USPQ2d 1849 (Fed. Cir. 2008), at 1851:
`
`The written description requirement of 35 U.S.C. § 112, 1] l, is straightforward: “The
`specification shall contain a written description of the invention ....” To satisfy this
`requirement, the specification must describe the invention in sufficient detail so “that one
`skilled in the art can clearly conclude that the inventor invented the claimed invention as
`of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 [41
`USPQ2d 1961] (Fed. Cir. 1997); see also LizardTecli, Inc. v. Earth Res. Mapping, Inc.,
`
`424 F.3d 1336, 1345 [76 USPQ2d 1724] (Fed. Cir. 2005); Eiselstein v. Frank, 52 F.3d
`
`1035, 1039 [34 USPQ2d 1467] (Fed. Cir. 1995).
`
`Alonso at 1852:
`
`A genus can be described by disclosing: (1) a representative number of species in that
`genus; or (2) its “relevant identifying characteristics,” such as “complete or partial
`structure, other physical and/or chemical properties, functional characteristics when
`coupled with a known or disclosed correlation between function and structure, or some
`combination of such characteristics.” Enzo, 323 F.3d at 964.
`
`23.
`
`In applying the test as set forth in Alonso, it is noted that applicant is claiming a generic
`
`method for modifying a nucleotide chain.
`
`24.
`
`Applicant, page 18, second paragraph, asserts that the resultant modified nucleotide chain
`
`can be used as a probe or target in gene analysis. As stated therein:
`
`Such a modifier may be a substance for labeling or conjugating a nucleotide chain. With
`such a configuration, the modified nucleotide chain can be used as a detection probe or
`target in gene analysis.
`
`

`

`Application/Control Number: 12/720,482
`
`Page 10
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`Art Unit: 1634
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`While target nucleic acids are generally known to exist, the use of the name “nucleic acid target”
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`neither constitutes an adequate written description, reasonably suggesting that applicant was in
`
`possession of the full genus of useful nucleic acid targets, nor allows one to recognize and
`
`distinguish those nucleic acids that are useful (under 35 USC 101) from those that are not. In
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`support of this position, attention is directed to the decision of Fiers v. Sugano 25 USPQ2d 1604—
`
`5 (CAFC, January 1993) wherein is stated:
`
`We also reject Fiers argument that the existence of a workable method for preparing a
`DNA establishes conception of that material. Our statement in Amgen that conception
`may occur, inter alia, when one is able to define a chemical by its method of preparation
`requires that the DNA be claimed by its method of preparation. We recognize that, in
`addition to being claimable by structure or physical properties, a chemical material can be
`claimed by means of a process. A product—by—process claim normally is an after—the—fact
`definition, used after one has obtained a material by a particular process. Before
`reduction to practice, conception only of a process for making a substance, without a
`conception of a structural or equivalent definition of that substance, can at most constitute
`conception of the substance claimed as a process. Conception of a substance claimed per
`se without reference to a process requires conception of its structure, name, formula, or
`definitive chemical or physical properties. .
`.
`>l<
`>l<
`>l<
`>l<
`
`The difficulty that would arise if we were to hold that a conception occurs when one has
`only an idea of a compound, defining it by its hoped—for function, is that would—be
`inventors would file patent applications before they had made their inventions and before
`they could describe them. That is not consistent with the statute or the policy behind the
`statute, which is to promote disclosure of inventions.
`
`Attention is also directed to the decision of University of California v. Eli Lilly and C0. (CA FC,
`
`July 1997) 43 USPQ2d 1398 wherein is stated:
`
`In claims involving chemical materials, generic formulas usually indicate with specificity
`what the generic claims encompass. One skilled in the art can distinguish such a formula
`from others and can identify many of the species that the claims encompass.
`Accordingly, such a formula is normally an adequate written description of the claimed
`genus. In claims to genetic material, however, a generic statement such as “vertebrate
`insulin cDNA” or “mammalian cDNA,” without more, is not an adequate written
`description of the genus because it does not distinguish the claimed genus from others,
`except by function. It does not specifically define any of the genes that fall within its
`definition. It does not define any structural features commonly possessed by members of
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`the genus that distinguish them from others. One skilled in the art therefore cannot, as
`one can do with a fully described genus, visualize or recognize the identity of the
`members of the genus. A definition by function, as we have previously indicated, does
`not suffice to define the genus because it is only an indication of what the gene does,
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`rather than what it is See Fiers 984 F.2d at 1169—71, 25 USPQ2d at 1605—06 (discussing
`Amgen). It is only a definition of a useful result rather than a definition of what it
`achieves as a result. Many such genes may achieve that result. The description
`requirement of the patent statute requires a description of an invention, not an indication
`of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d
`1516, 222 USPQ 369, 372—373 (Fed. Cir. 1984) (affirming rejection because the
`specification does “little more than outlin[e] goals appellants hope the claimed invention
`achieves and the problems the invention will hopefully ameliorate”). Accordingly,
`naming a type of material generally known to exist, in the absence of knowledge as
`to What that material consists of, is not a description of that material. (Emphasis
`added)
`
`Thus, as we have previously held, a cDNA is not defined or described by the mere
`name “cDNA,” even if accompanied by the name of the protein that it encodes, but
`requires a kind of specificity usually achieved by means of the recitation of the sequence
`of nucleotides that make up the cDNA. See Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606.
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`25.
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`While an applicant is not required to teach each and every possible embodiment
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`encompassed by the claims, the specification still must provide a full, clear, and concise
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`description of the genus encompassed by the claims so that one would be readily able to
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`determine if a species fell within the claims’ scope, and to also reasonably suggest that applicant
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`had possession of the invention at the time of filing. In support of this position, attention is
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`directed to the decision in In re Shaka], 113 USPQ 283 (CCPA 1957) wherein is stated:
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`It appears to be well settled that a single species can rarely, if ever, afford sufficient
`support for a generic claim. In re 5011, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38
`USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.2d 270, 48 USPQ
`397. The decisions do not however fiX any definite number of species which will
`establish completion of a generic invention and it seems evident therefrom that such
`number will vary, depending on the circumstances of particular cases. Thus, in the case
`of small genus such as the halogens, consisting of four species, a reduction to practice of
`three, or perhaps even two, might serve to complete the generic invention, while in the
`case of a genus comprising hundreds of species, a considerably larger number of
`reductions to practice would probably be necessary.
`*>k>l<
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`We are of the opinion that a genus containing such a large number of species cannot
`properly be identified by the mere recitation or reduction to practice of four or five of
`them. As was pointed out by the examiner, four species might be held to support a genus,
`if such genus is disclosed in clear language; but where those species must be relied on not
`only to illustrate the genus but to define what it is, the situation is otherwise.
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`26.
`
`In the present case, a review of the disclosure has found a Sequence Listing that
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`comprises but 3 sequences, all three of which are identified as being DNA, and “Artificial.”
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`27.
`
`A review of the disclosure fails to find where applicant has provided an adequate written
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`description of the full genus of nucleic acids that have utility under 35 USC 101 whereby one
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`would be able to distinguish a nucleic acid that has utility from one that lacks utility.
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`28.
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`As amended, claim 1 now recites the “binding a modifier having an amino group to the
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`3 ’—terminal of the nucleic acid.” A review of the disclosure fails to find an adequate written
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`description of the members of the genus of modifiers that have an amino group which have
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`utility in the claimed method.
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`29.
`
`Attention is directed to the decision of Vas-Cath Inc. v. Mahnrkar 19 USPQ2d 1111
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`(CAFC, 1991):
`
`This court in Wilder (and the CCPA before it) clearly recognized, and we hereby
`reaffirm, that 35 USC 112, first paragraph, requires a “written description of the
`invention” which is separate and distinct from the enablement requirement. The
`purpose of the “written description” requirement is broader than to merely explain
`how to “make and use”; the “applicant must also convey with reasonable clarity
`to those skilled in the art that, as of the filing date sought, he or she was in
`possession of the invention. The invention is, for purposes of the “written
`description” inquiry, whatever is now claimed.
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`30.
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`It appears that applicant is attempting to satisfy the written description requirement of 35
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`USC 112, first paragraph, through obviousness. Obviousness, however, cannot be relied upon
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`for satisfaction of the written description requirement. In support of this position, attention is
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`directed to the decision in University of California v. Eli Lilly and Co. (Fed. Cir. 1997) 43
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`USPQ2d at 1405, citing