DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2025 has been entered.
Status of the Application
Claims 7-22 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 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 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.
Claims 14-22 are rejected under 35 U.S.C. §112, first paragraph, as failing to comply with the written description requirement. The claim(s) contain subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the invention was filed, had possession of the claimed invention.
The instant claims are directed to a genus of compound:
PNG
media_image1.png
766
902
media_image1.png
Greyscale
PNG
media_image2.png
507
868
media_image2.png
Greyscale
Thus, claims 14-22 are drawn to millions of compounds, having large variation in core itself with respect to a non-nucleosidic moiety, with R, R1, PA, L1, W and G with optional substitutions, each moiety very different structurally from another, are attached.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP §2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within the genus. See MPEP §2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad genus. In Gostelli the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 19 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-LaRoche Inc., Nos. 07-1266-1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter claimed by him.
The applicants have broadly claimed a compound. MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 14-22 are broad and generic, with respect to all possible compounds encompassed by claim 14. There is a very large number of structural variations encompassed by the instant claims. The claims lack in written description because the specification lacks sufficient variety of species to reflect this variance in the genus. The specification provides guidance to a limited number of compounds embraced by claim 14; the common structural features in the examples disclosed are:
Non-nucleosidic moiety with G with carbonyl moiety
PNG
media_image3.png
126
350
media_image3.png
Greyscale
with respect to core E1 =E=CH2 or (CH2)2;
A1=A= CH2 or (CH2)2;
OR1 or OR=OTMT; ODMT; OAc; OH; OPA=
PNG
media_image4.png
95
164
media_image4.png
Greyscale
; and (C=O)CH2CH2COOH; and
G as
PNG
media_image5.png
71
642
media_image5.png
Greyscale
X1, X2 X3 as (C=O)NH, NH(C=O) or CH2 and J as:
H, OH, NH2, N-acetyl-D-galactosamine
and W = aminopropyl solid phase.
Thus, the specification does not provide sufficient descriptive support for the myriads of compounds embraced by the claims.
There are millions of combinations of functional elements, embraced by claims 14-22. Considering the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of claims 14-22.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The 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 U.S.C. 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.
Claim(s) 14-22 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention (see M.P.E.P 608.01 (k)).
Claims 14-22 are indefinite because:
Claim 14 recites “G is a substituted aliphatic ---from 4-55 carbons” and then recites “G comprises a C(=O) adjacent the ring”, which reflects use of broad and narrower limitation within the same claim. This is because the claim recites G can be any group or functionality having C=O group and the claim also recites G is a is a substituted aliphatic ---from 4-55 carbons. Thus, scope of the claim is unclear.
Claim 14 is also indefinite as the claim recites “an optionally protected OH--- a hydroxy group alkylated with optionally protected-----sulfonic acid”, which reflects use of broad and narrow limitation within the same claim. Thus, scope of the claim is unclear.
Claim 14 is indefinite as the claim recites L1 as:
PNG
media_image6.png
112
750
media_image6.png
Greyscale
, which reflects use of narrow and broad limitations within the same claim. This is because L1 is a terminal group and the alternatives recited have either L1 group terminated with OH, W1, W or just open to any group. Thus, scope of claim is unclear.
Claim 20 is indefinite as the claim recites “an optionally protected OH--- a hydroxy group alkylated with optionally protected-----sulfonic acid”, which reflects use of broad and narrow limitation within the same claim. Thus, scope of the claim is unclear.
Response to Arguments
Applicant’s remarks, and amendment, as filed on 08/04/2025, have been fully considered but not found persuasive.
Applicant argue over rejection under 112a, written description, that disclosure of a representative number of species is “sufficient” if one of skill in the art recognize that the applicant was in possession of necessary common attributes or features possessed by the members of the genus in view of the species disclosed. Applicant argues that specification satisfies the written description requirement of amended claim 14 by actual reduction to practice as in the instant specification 0033, 0045 and 0046 and argued over no unwanted side reactions, create no new chiral centers in oligonucleotides.
PNG
media_image7.png
630
1000
media_image7.png
Greyscale
PNG
media_image8.png
766
653
media_image8.png
Greyscale
PNG
media_image9.png
766
675
media_image9.png
Greyscale
PNG
media_image10.png
766
702
media_image10.png
Greyscale
PNG
media_image11.png
766
665
media_image11.png
Greyscale
This is not found persuasive and the instant claims stand rejected under 112a, written description. If the applicant would have defined representative number of species representing millions of variations, there would not be a rejection under 112a. Importantly, just naming different variables such as R, R1, W, G, J etc. different variations, derivatives, comprising different groups and a genus, without actually providing species which are representative of claimed genus of Formula I does not satisfy written description requirement and is not “sufficient”. A "representative number of species" means that the species which are adequately described are representative of the entire genus (i.e., not just different variables and substituents). Instant claims are not drawn to individual variables such as R, R1, W, G, J etc., but to a compound of Formula I. The instant specification lacks representative examples of compound of formula I. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.")
As reproduced below paragraphs 033, 0045 and 0046:
PNG
media_image12.png
211
834
media_image12.png
Greyscale
PNG
media_image13.png
673
846
media_image13.png
Greyscale
neither provides any synthetic method nor support for millions of species encompassed by the instant claims. Contrary to applicant’s remarks, the specification along with indicated example provide guidance to a limited number of compounds embraced by claims7-13; the common structural features in the examples disclosed are:
Non-nucleosidic moiety with G with carbonyl moiety
PNG
media_image3.png
126
350
media_image3.png
Greyscale
with respect to core E1 =E=CH2 or (CH2)2;
A1=A= CH2 or (CH2)2;
OR1 or OR=OTMT; ODMT; OAc; OH; OPA=
PNG
media_image4.png
95
164
media_image4.png
Greyscale
; and (C=O)CH2CH2COOH; and
G as
PNG
media_image5.png
71
642
media_image5.png
Greyscale
X1, X2 X3 as (C=O)NH, NH(C=O) or CH2 and J as:
H, OH, NH2, N-acetyl-D-galactosamine
and W = aminopropyl solid phase.
Thus, the specification does not provide sufficient descriptive support for the myriads of compounds embraced by the claims.
With regard to Applicant’s argument that the method of using different support systems, derivitization etc. is also well known in the art -is again not found persuasive. This is because applicant only argues but provided no evidence where the compound of the instant claims or closely similar compounds linked with such variations of support W, and a process of making is known.
Please note that attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
Applicant argued over R and R1 that the instant specification provides support for MMT, DMT---xanthen-9-yl and L1 as (C=O)CH2CH2COOH or (C=O)CH2CH2COO-W1.
This is not found persuasive and the instant claims stand rejected under 112a. This is because applicant is mainly repeating specific R and R1 that examiner already mentioned in the rejection that the applicant has the support. Applicant is not responding to the rejection of vast number of generic groups that claim encompass and has no support in terms of written description. For instance, W1, where applicant has only support for aminopropyl solid phase.
Applicant argued over X1-X3 that the broad claims are therefore supported.
This is not found persuasive and the instant claims stand rejected under 112a. This is because providing two examples, in which ligand is absent in both examples and claiming millions of linkers with any hydrocarbon comprising three carbons, derivatives thereof, any combination thereof along with diverse ligands:
PNG
media_image14.png
402
959
media_image14.png
Greyscale
is not a support for such compounds. In conclusion, applicants have broadly claimed a compound. MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 14-22 are broad and generic, with respect to all possible compounds encompassed by the instant claims. There is a very large number of structural variations encompassed by instant claims. The claims lack in written description because the specification lacks sufficient variety of species to reflect this variance in the genus.
Rest of applicant’s argument is moot in view of new rejection as set forth above.
Allowable Subject Matter
Claim 7-13 presents allowable subject matter over the prior art on record.
Objection
Claim 7-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Milligan Adam can be reached on 571-2707674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623