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 .
DETAILED ACTION
Election Restrictions
1. Applicant’s election without traverse of Group II and species (SEQ ID NO: 3; SEQ ID NO: 2) in the reply filed on 3/12/2026 is acknowledged.
Claims 27-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/12/2026.
Claims 37-46 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 7/19/2923. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
4. The drawings are objected to because:
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
5. Claim 40 is objected to because of the following informalities:
Claim 40 recites “the aminos acid sequence”, which appears to be a typo.
Appropriate correction is required.
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.
6. Claims 37-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 37-46 as submitted 4/25/2023.
As to claim 37, the claim recites “a method for the prevention or the treatment of a disease or a disorder, comprising administering a peptide comprising a lipid binding amino acid sequence (LBD) derived from filensin (BFSP1), or a functional variant or functional fragment thereof capable of binding to a lipid or the recombinant peptide according to claim 1 to a subject in need thereof”. It is not clear if the claim intends that the functional fragment is capable of binding to a lipid or the recombinant peptide according to claim 1 or not. For clearer language, the claim should recite “comprising administering the recombinant peptide according to claim 1, or a peptide comprising a lipid binding amino acid sequence (LBD) derived from filensin (BFSP1), or a functional variant or functional fragment thereof capable of binding to a lipid, to a subject in need thereof”.
Further as to claims 41, 44, it is not clear if the method further comprises adding an OD or bioactive agent separately, or if the peptide further comprises the OD or the bioactive agent. The relationship between the components recited in claims 41, 44 and claim 37 is not clear.
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.
7. Claims 37-46 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.
See claims 37-46 as submitted 4/25/2023.
Each of the claims is drawn, inherently or explicitly, to lipid binding amino acid sequences derived from filensin, BFSP1, functional variants or functional fragments thereof capable of binding to a lipid or recombinant peptides comprising lipid binding amino acid sequences derived from filensin, BFSP1, functional variants or functional fragments thereof capable of binding to a lipid. Further, the claims are also drawn to amino acid sequence SEQ ID NO: 3 (elected species) and functional variants and functional fragments thereof capable of binding to a lipid, including wherein the functional variant or functional fragment has a sequence with up to 10 amino acid difference from SEQ ID NO: 3; wherein the functional variant or functional fragment has a sequence with up to 8 amino acid difference from SEQ ID NO: 3; as well as ODs derived from BFSP1 (SEQ ID NO: 2; elected species); IM derived from SARS-CoV-2.
Thus, the claims are drawn to compositions comprising a genus of peptides comprising sequences derived from filensin (BFSP1) and functional variants or fragments thereof. Additionally, the claims are drawn to a genus of oligomerization domains and immunogenic agents. Further, the instant claims also read on a genus of “any” peptides comprising sequences derived from filensin (BFSP1) and functional variants or fragments thereof as well as a genus of oligomerization domains and immunogenic agents.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification teaches: construct comprising LBD, OD, and IM, an wherein LBD has a length of up to 150 amino acids (p. 1); including SEQ ID NO: 1 (hBFSP1 G434-T460)(p. 2); SEQ ID NO: 3; including oligomerization domains SEQ ID NO: 2 (p. 2); wherein functional variants or fragments are capable of binding of lipids (p. 5), including wherein fragments are SEQ ID NOs: 1, 130, 3 (p. 6); as well as embodiments such as TFR123 (p. 14; used in Examples I-X).
However, it is known in the art that protein structure determines protein function and binding functions are unpredictable. As to BFSP1, a 230 amino acid stretch appeared to show 4 binding domains as evidenced by Quinlan et al. ("The interaction of BFSP and its proteolytically derived fragments with cell membranes," ARVO Annual Meeting Abstract, Investigative Opthalmology & Visual Science, Vol.57, 3074 (2016))(cited in the Restriction Action issued 2/13/2026). Quinlan et al. teaches: BFSP1 fragments; including sequences 434-665 containing 4 lipid binding domains; including 434-665 containing 4 lipid binding domains; including wherein 434-460 sequence is capable of binding directly to membranes and capable of targeting GFP. While this 434-460 sequence is sufficient to partition tag to compartment, another mechanism likely exists for the other sequences. Thus, Quinlan et al. teaches that different sequences of BFSP1 apparently use different mechanisms, direct versus indirect.
Further, it is known that even minor changes can alter function. For example, Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982))(See PTO-892: Notice of References Cited) teaches: that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function (p. 1979). Further, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References Cited) teaches: a single amino acid change may alter the immunological information of a peptide (title).
Thus, while the specification as indicated above identifies TFR123 and SEQ ID NOs: 1, 2, 130, 3, in view of the breadth of the claims and the challenges known in the art, it does not identify a representative sample of sequences, variants, fragments, and derivatives especially in view of the breadth of the claims. Thus, the application does not identify a representative sample within the breadth of the claimed genus.
There is no apparent common conserved structure to the different sequences, variants, fragments, and derivatives that distinguishes those that bind to lipids as compared to those that do not. There is therefore a high level of uncertainty as to which sequences, variants, fragments, and derivatives fall within the scope of the indicated genus.
Further, the specification has identified peptides only by function: the ability to bind to lipids. The specification does not provide a specific structure of any sequences, variants, fragments, and derivatives within the genus that correlates with the required function. Because there is no identification of structures common to each sequence, variant, fragment, and derivative, nor sufficient representative examples by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of sequences, variants, fragments, and derivatives through identification of a structure and function. While the sequences, variants, fragments, and derivatives are required to bind to lipids, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a sequence, variant, fragment, and derivative does not demonstrate that it would be able to bind to lipids.
For the reasons above, the application has not provided sufficient written description support for the genus of sequences, variants, fragments, and derivatives identified in claims 37-46. The application therefore fails to provide adequate support for methods of using this genus of sequences, variants, fragments, and derivatives.
8. Claims 37-46 are 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 treatment including of SARS-CoV-2 infection, does not reasonably provide enablement for prevention of any disease or disorder. 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.
See claims 37-46 as submitted 4/25/2023.
In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantityof experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6)the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) thebreadth of the claims. Id. While it is not essential that every factor be examined in detail, thosefactors deemed most relevant should be considered. In the present case, the factors deemedrelevant are those of the amount of direction and the working examples provided, that quantity ofexperimentation necessary, and the breadth of the claims.
Breadth of the claims: Claim 37 recites method for the prevention or the treatment of a disease or disorder. Such a recitation reads on prevention of “any” disease or disorder. Further, claim 37 only recites administration of peptide comprising lipid binding domain derived from filensin (BFSP1).
State of the art: The art teaches wherein BFSP1 is a key structural element required for lens function (See Perng et al. “Insights into the beaded filament of the eye lens,” Exp Cell Res 10:313 (10): 2180-2188 (2007))(See PTO-892: Notice of References Cited). Fotin Mleczek et al. (cited below) teaches BFSP1 and administration of RNA and protein therapeutics.
Teaching in the specification: See specification disclosures as indicated above. As also noted by the instant specification, filensin is a cytoskeletal protein expressed in the eye lens (p. 1); Constructs incorporating LBD of BFSP1 such as TFR123 are used with respect to SARS-CoV-2 alone (p. 14; used in Examples I-X).
However, in view of the breadth of the claims reciting prevention of any disease or disorder and the specification limited to teachings with respect to SARS-CoV-2 alone, the skilled artisan would be required to conduct undue amount of experimentation in order to use the claimed peptides for preventing any disease. While the art teaches use of structural properties with BFSP1 and general therapeutic effect, such applications do not appear to apply directly to prophylactic applications with respect to any disease or disorder.
As discussed above undue experimentation would be required to practice the claimedinvention commensurate with the scope of the claims. Reasonable correlation must exist betweenthe scope of the claims and scope of enablement set forth. In view of the quantity ofexperimentation necessary, the limited working examples, the unpredictability of the art, the lackof sufficient guidance in specification, and the breadth of the claims, it would take undue trialsand errors to practice the claimed invention.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
9. Claims) 37, 39-45 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fotin-Mleczek et al. (WO2017191274)(See PTO-892: Notice of References Cited).
See claims 37, 39-45 as submitted 4/25/2023.
Fotin-Mleczek et al. teaches: RNAs and encoded proteins for use in gene therapy (abstract); RNA therapeutic proteins; including SEQ ID NO: 1140 (human therapeutic protein BFSP1 (p. 20))(therapeutic protein encoded by RNA (claim 2 of Fotin-Mleczek et al.), which has 100% identity with instant SEQ ID NOs: 2, 3 (as recited in claims 39, 40, 41, 42, 43)(See Result 17 of STIC Sequence Search 20260407_230429_us-18-033-648d-2.rag in Supplemental Content Tab as to SEQ ID NO: 2 as well as Result 27 of STIC Sequence Search 20260407_230429_us-18-033-648d-3.rag in Supplemental Content Tab as to SEQ ID NO: 3; it is noted claims 39, 43 recite wherein the LBD comprises SEQ ID NO: 3; OD comprises SEQ ID NO: 2); administration (p. 93)(as recited in claim 37); adjuvant (pages 4, 8), adjuvant proteins (p. 16)(as recited in claims 44, 45).
Thus, Fotin-Mleczek et al. anticipates or renders obvious the instant claims.
10. Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Fotin-Mleczek et al. as applied to claims 37, 39-45 above, and further in view of Klein et al. (“Design and characterization of structured protein linkers with differing flexibilities,” Protein Engineering, Design & Selection, Vol. 27, No. 10: 325-330 (2014))(See PTO-892: Notice of References Cited).
See claim 38 as submitted 4/25/2023.
See the teachings of Fotin-Mleczek et al. above. It is noted Fotin-Mleczek et al. teaches the use of flexible linkers (p. 49).
Fotin-Mleczek et al. does not teach: wherein a linker sequence GG is attached to the
LBD comprised in the peptide or the recombinant peptide.
Klein et al. teaches: use of protein linkers (abstract), including flexible linkers (p. 325); including Gly4Ser, including repeats (p. 325), which comprises GG; design of flexible linkers (title).
One of ordinary skill in the art would have been motivated to use linker as taught by Klein et al. with the construct as taught by Fotin-Mleczek et al. Fotin-Mleczek et al. teaches the use of linkers, and Klein et al. teaches such a linker (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to the number of glycines, in view of Klein et al. teaching use and design of flexible linkers, the numbers of glycine chosen are considered to be those be determined by routine optimization to one of ordinary skill in the art in view of Fotin-Mleczek et al. in view of Klein et al. (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
One of ordinary skill in the art would have had a reasonable expectation of success for using linker as taught by Klein et al. with the construct as taught by Fotin-Mleczek et al. There would have been a reasonable expectation of success given the underlying materials (constructs as taught by Fotin-Mleczek et al. and Klein et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
11. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 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, Thomas Visone can be reached at 571-270-0684. 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.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
Prosecution Insights