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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/11/2022 before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-7 are pending. Claims 1-7 are under examination.
Claim Objections
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 4, para. 9, filed 1/7/2026, with respect to claims 1-7 have been fully considered and are persuasive. Amended claims 1-7 correct the informalities of articles, sequence identifier format, and conjunction issues. The objections to claims 1-7 have been withdrawn.
Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 5, para. 4, filed 1/7/2026, with respect to claims 1-7 have been fully considered and are persuasive. The amended claim set removes the indefiniteness issues raised under U.S.C. 112(b) by the previous claim set. The rejection of claims 1-7 has been withdrawn.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 5, para. 4, filed 1/7/2026, with respect to claims 4, 6, and 7 have been fully considered and are persuasive. The amended claim set remedies raised under U.S.C. 112(d) by the previous claim set. The rejection of claims 4, 6, and 7 has been withdrawn.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 6, para. 2, filed 1/7/2026, with respect to the rejection of claims 6 and 7 under U.S.C. 112(a) have been fully considered and are persuasive. The amended claims address the enablement issues raised by the previous claim set. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of amended claims 1 and 4.
New Rejections
The following is a quotation of the first paragraph of 35 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 1-7 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Regarding claim 1, amended claim 1 recites a peptide having 16 to 50 amino acids, wherein the peptide comprising comprises a peptide having the following sequence:DRX3GKKVKRWDMKX14RH (SEQ ID NO: 1) wherein X3 and X14 are independently of each other any amino acid.
Previously, claim 1 recited “… a peptide of…”.
MPEP 2111.03(IV) states: “Transitional phrases such as "having" must be interpreted in light of the specification to determine whether open or closed claim language is intended. See, e.g., Lampi Corp. v. American Power Products Inc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453 (Fed. Cir. 2000).”
Also, the specification only provides support for the phrase “… a peptide of…”: “Therefore an object of the present invention concerns a peptide of 16 to 50 amino acids comprising a peptide having the following sequence: DRX3GKKVKRWDMKX14RH (SEQ ID NO: 1) wherein X3 and X14 are independently of each other any amino acid.” (Specification, page 5, line 30).
Consequently, because the transitional phrase “having” may be interpreted as “comprising”, amended claim 1 has broadened the scope of claim 1 to include new matter unsupported by the specification.
Claim 1 is rejected.
Regarding claims 2-7, these claims depend from claim 1 and do not remove the new matter.
Claims 2-7 are rejected.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a Wnt/β-catenin and/or Hippo/YAP/TAZ pathway-related disease, does not reasonably provide enablement for treating any possible disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP 2164.01(a) states: “In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is ‘reasonable’ or is ‘undue.’”
These factors include, but are not limited to:
The breadth of the claims;
The claim in question is not broad with respect to the peptide, but the genus of all diseases is enormous.
The nature of the invention;
The invention is a method of treating a disease in a subject, the method comprising: administering to the subject a therapeutically effective amount of the peptide according to claim 1.
The state of the prior art;
The Wnt/β-catenin pathway is well-known to be involved with cancer (Arend., et al. Gynecologic oncology 131.3: 772-779 (2013)), osteoporosis (Rossini, et al. Calcified tissue international 93.2: 121-132 (2013), and osteoarthritis (Stampella, et al., Best Practice & Research Clinical Rheumatology 31.5: 721-729 (2017)). The potential efficacy of this pathway as a treatment for these disorders is not in dispute.
However, diseases have many other causes such as microbes as discussed by Singh (Singh, et al. J Appl Environ Microbiol 2.4: 106-115 (2014)): “Microbes are called disease-causing microbes and can make humans, animals and plants sick by causing infection and disease. Disease-causing microbes can also be called pathogens, germs or bugs and are responsible for causing infectious diseases. Microorganisms are very diverse. They include all of the prokaryotes, namely the bacteria and archaea and various forms of eukaryotes, comprising the protozoa, fungi, algae, microscopic plants (green algae), and animals such as rotifers and planarians. Some microbiologists also classify viruses as microorganisms, but others consider these as nonliving.” (Singh et al., page 106, Abstract).
Furthermore, Vogelstein (Vogelstein, et al. Nature medicine 10.8: 789-799 (2004)). discloses that cancer can be caused by many different pathways: “Oncogene and tumor-suppressor gene mutations all operate similarly at the physiologic level: they drive the neoplastic process by increasing tumor cell number through the stimulation of cell birth or the inhibition of cell death or cell-cycle arrest. The increase can be caused by activating genes that drive the cell cycle, by inhibiting normal apoptotic processes or by facilitating the provision of nutrients through enhanced angiogenesis (Figs. 2,3,4). A third class of cancer genes, called stability genes or caretakers, promotes tumorigenesis in a completely different way when mutated. This class includes the mismatch repair (MMR), nucleotide-excision repair (NER) and base-excision repair (BER) genes responsible for repairing subtle mistakes made during normal DNA replication or induced by exposure to mutagens.” (Vogelstein, et al., page 789, col. 2, para. 2). Vogelstein also reviews many pathways in a schematic form (Vogelstein et al., Figures 1-9).
The level of one of ordinary skill;
The level of one of ordinary skill in this art is relatively high; at least a master’s level education and likely a doctorate level education.
The level of predictability in the art;
Unfortunately, the predictability of cancer is still a challenge. Valle et al. describes cancer prevention: “Rather than being “one-size-fits-all”, P4 medicine is individually
tailored to the specific needs of the patient.” (Valle, et al. Journal of preventive medicine and hygiene 56.1: E21 (2015), page E22, col. 1, para. 2).
Furthermore, Gallagher et al. describes the hit-and-miss nature of osteoarthritis prevention:
“A total of 3514 studies were identified from the initial search, 13 of which met inclusion criteria. Treatment with chondroitin sulfate showed a significant reduction in cartilage loss in 3 of 4 studies identified compared with placebo. Two of 3 trials identified for glucosamine also reported significant structural effects relative to placebo. Intra-articular hyaluronic acid was effective in lowering the rate of cartilage loss in only 1 of 3 studies identified versus placebo. Of the 6 studies identified for NSAIDs, vitamin E, and vitamin D, none showed any structural effect compared with placebo. No studies were found that met the inclusion criteria for polyunsaturated
fatty acids, S-adenosylmethionine, avocado and soybean unsaponifiable fractions, methylsulfonylmethane, vitamin C, or PRP.”
(Gallagher, et al. The American journal of sports medicine 43.3: 734-744 (2015)).
The amount of direction provided by the inventor and the existence of working examples; and The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Applicant provides convincing evidence that the claimed peptides can affect the Wnt/β-catenin pathway, the Hippo/YAP/TAZ pathway, and the CamKII pathway. Therapeutic benefits, i.e. treatment, flows from this evidence.
Regarding claim 4, the provided support in the specification is limited to the Wnt/β-catenin pathway, the Hippo/YAP/TAZ pathway, and the CamKII pathway. As described above, the genus of all disease encompasses far more causes than these pathways. A person of ordinary skill in the art cannot use the invention commensurate in scope with these claims with respect to prevention of the claimed diseases. Consequently, claim 4 is rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by La Rosa et al. US 20040031072, published 2/12/2004.
Regarding claim 1, the application US US20040031072-A1 discloses SEQ ID NO: 143572, which is aligned with Applicant SEQ ID NO: 2 below:
SQ Sequence 68 AA;
Query Match 100.0%; Score 89; Length 68;
Best Local Similarity 100.0%;
Matches 16; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DRLGKKVKRWDMKLRH 16
||||||||||||||||
Db 23 DRLGKKVKRWDMKLRH 38
This is a match with Applicant’s claimed sequence in the case where X3 and X14 are leucine.
Amended claim 1 uses the transition phrase “having”. MPEP 2111.03(IV) states: “Transitional phrases such as "having" must be interpreted in light of the specification to determine whether open or closed claim language is intended. See, e.g., Lampi Corp. v. American Power Products Inc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453 (Fed. Cir. 2000).”
It is not clear whether open or closed language is intended, so the broadest reasonable interpretation is that of “comprising”. Consequently, the peptide disclosed by LaRosa anticipates Applicant claim 1.
Claim 1 is rejected.
Regarding claim 2, claim 1 is anticipated as described above. The peptide of LaRosa has a leucine at X3 and X14. Consequently, the peptide disclosed by LaRosa anticipates Applicant claim 2.
Claim 2 is rejected.
Regarding claim 3, claim 1 is anticipated as described above. The sequence of LaRosa is aligned against Applicant SEQ ID NO: 2 above. Consequently, the peptide disclosed by LaRosa anticipates Applicant claim 3.
Claim 3 is rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over La Rosa et al. US 20040031072, published 2/12/2004 in view of Chaudhari, et al. Int J Adv Pharm Biol Chem 1.1: 21-34 (2012)).
Regarding claim 5, claim 1 is anticipated as described above. Chaudhari describes the benefits of pharmaceutical excipients:
“Protect, support or enhance stability of the formulation:- Most of the times it is observed that the active pharmaceutical ingredient in its pure form does not retain its stability for long which results in its denaturation, or sticking to the container wall thus rendering it unfit, hence in order to stabilize the API excipients are added which aid in maintaining the stability of the product and ensures that API retains its stability for a considerable period of time thus improving the shelf life of dosage formulation.” (Chaudhari, et al., page 21, col. 1, para. 1).
Chaudhari also discloses numerous common excipients (Chaudhari, et al., page 28, Table 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the peptide of LaRosa with the excipients of Chaudhari to arrive at the claimed invention.
A person of ordinary skill in the art would be motivated to add excipients to capture the benefits described by Chaudhari and have a reasonable expectation of success because Chaudhari discloses that excipients are routinely added to pharmaceutical compositions (Chaudhari, et al., page 28, Table 1).
Consequently, claim 5 is obvious over La Rosa et al. in view of Chaudhari et al. and rejected.
Closest Prior Art
Regarding the method claims 4, 6, and 7, the prior art does not disclose any teaching, suggesting, or motivation to use the peptide of LaRosa described above for the treatment of disease. The LaRosa reference is directed to plant transcription, and does not suggest any usage in animals. Nor does any related art suggest such a usage.
Conclusion
Claims 1-7 are rejected.
Applicant's amendment necessitated the new ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654