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 .
Election/Restrictions
Applicant’s species election without traverse of the recombinant resilin protein identified in SEQ ID NO: 13 with an alpha mating factor secretion signal and a FLAG-tag in the reply filed on December 17, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Election was made without traverse in the reply filed on December 17, 2025.
Claims 1, 2, 6-10, 12-19, and 69-71, drawn to the elected species are currently pending and under examination. If the species is not identified in the prior art, then another species will be examined.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is January 13, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 12, 2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Drawings
The drawings are objected to because Figure 10 discloses an amino acid sequence that does not appear to correspond to the SEQ ID NO: identifier, SEQ ID NO: 1. Suggest identifying the amino acid sequence with the SEQ ID NO: identifier that corresponds with the disclosed sequence in figure 10. 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.
Specification
The disclosure is objected to because of the following informalities: Figure 10 discloses an amino acid sequence that does not appear to correspond to the SEQ ID NO: identifier, SEQ ID NO: 1. Suggest identifying the amino acid sequence with the SEQ ID NO: identifier that corresponds with the disclosed sequence in figure 10.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 6-10, 12-19, and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 10,988,515 B2 (March 12, 2024 IDS, Patent document #3). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are of overlapping scope. The claims of the issued patent are drawn to methods of producing a composition comprising a recombinant resilin protein. The term composition is disclosed to encompass gels. The claims of the issued patent are also drawn to vectors, recombinant host cells, and fermentation comprising the cells. The currently pending resilins are species of the claimed species of the issued patent. It would have been obvious to the person having ordinary skill in the art to make and use the currently claimed resilins, because the issued patent discloses species that overlap in scope with the pending claims. Both resilins have use for similar compositions based on the resilins resilient and elastic properties, which are useful for biomaterial forming proteins.
Claims 1, 2, 6-10, 12-19, and 69-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,858,971 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are of overlapping scope. The claims of the issued patent are drawn to methods of producing a composition comprising a recombinant resilin protein. The composition can be a cross-linked recombinant resilin in a gel format (see claim 21). The claims of the issued patent are also drawn to vectors, recombinant host cells, and fermentation comprising the cells. The currently pending resilins are species of the claimed species of the issued patent. It would have been obvious to the person having ordinary skill in the art to make and use the currently claimed resilins, because the issued patent discloses species that overlap in scope with the pending claims. Both resilins have use for similar compositions based on the resilins resilient and elastic properties, which are useful for biomaterial forming proteins.
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 18 is 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.
Claim 18 recites the limitation "the soluble full-length resilin" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not refer to the full-length resilin.
Claim Rejections - 35 USC § 112
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 12 and 14 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.
The claim is rejected for failing to describe the components of the fermentation that results in the rate of at least 2 mg/ g dry cell weight/ hour as currently claimed. The claim is drawn to a composition but does not describe the elements in the composition that results in the functional limitations. The art cited below shows a fermentation of a host cell with a vector that comprises a secreted resilin coding sequence but does not produce the secretion of the resilin in the concentration as currently claimed. Therefore, the current claim is lacking in description of the vector or host cell or media that provides for the functional concentration intended for the fermentation being claimed.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state 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. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. 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, 10 USPQ2d at 1618.
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. Claims are broadly generic to all possible fermentation compositions encompassed by the claims. The possible variations are enormous. Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure.
The description requirement of the patent statue 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, 1521, 222 USPQ 369, 372-73 (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, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 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(s) 1, 2, 7, 8, 13, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Azam et al. (Biotechnology and Bioengineering 113: 2313-2320 (2016) (March 12, 2024 IDS, NPL document #4) in view of US 2014/0206022 A1 (March 12, 2024 IDS, U.S. Patent Application Publication document #4; see sequence below from SCORE search).
Azam et al. disclose the recombinant expression and purification of a secreted resilin coding sequence. The use of a secretion system was employed for export of the recombinant resilin from the bacterial strain (see page 2314, left hand column). The plasmid vector used has a C-terminal FLAG tag (see Table 1). The target proteins were purified by gravity-flow nickel affinity chromatography (see entire document, particularly pages 2316, The Secreted Peptides are of High Purity Compared to Those Harvested from the Cytoplasm, and 2317 figures 1 and 2). Figure 2 shows the purity of resilin protein expression from both a secreted fraction and a pellet fraction that was purified. The pellet was obtained by centrifugation of the fermentation media.
Azam et al. does not disclose the resilin coding sequence selected from the group of SEQ ID NOs: currently pending, but it would have been obvious to the person having ordinary skill in the art to use the pending SEQ ID NO: because SEQ ID NO: 26 was known Drosophila resilin protein as disclosed by Nuti et al. (US 2014/0206022 A1; SEQ ID NO: 12).
In KSR, the Supreme Court particularly emphasized "the need for caution in granting a patent based on the combination of elements found in the prior art,"Id. at 415, 82 USPQ2d at 1395, and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results."Id. at 415-16, 82 USPQ2d at 1395.
Combining prior art elements according to known methods to yield predictable results is an exemplary rational to support a conclusion of obviousness. It is not inventive to use known resilin protein sequences such as Drosophila resilin (Nuti et al., SEQ ID NO: 12), since Azam et al. disclose the use of resilin for recombinant expression as currently encompassed by the pending claims.
SCORE: 20260508_080459_us-18-533-639b-26.rapbm file.
RESULT 2
US-14-108-182-12
Filing date in PALM: 2013-12-16
Sequence 12, US/14108182
Publication No. US20140206022A1
GENERAL INFORMATION
APPLICANT: Nuti, Gina M.
APPLICANT: Verardo, Mark R.
APPLICANT: Messina, Darien J.
TITLE OF INVENTION: Three-Dimensional Cell Culture Methods for Test Material
TITLE OF INVENTION: Assessment of Cell Differentiation
FILE REFERENCE: 19109 (BRE)
CURRENT APPLICATION NUMBER: US/14/108,182
CURRENT FILING DATE: 2013-12-16
PRIOR APPLICATION NUMBER: US 61/738,125
PRIOR FILING DATE: 2012-12-17
NUMBER OF SEQ ID NOS: 117
SEQ ID NO 12
LENGTH: 633
TYPE: PRT
ORGANISM: Drosophila virilis
Also in US-61-738-125-12
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 12, US/61738125
GENERAL INFORMATION
APPLICANT: Nuti, Gina M.
APPLICANT: Verardo, Mark R.
APPLICANT: Messina, Darien J.
TITLE OF INVENTION: Three-Dimensional Cell Culture Methods for Matrix Assessment
FILE REFERENCE: 19109PROV (BRE)
CURRENT APPLICATION NUMBER: US/61/738,125
CURRENT FILING DATE: 2012-12-17
NUMBER OF SEQ ID NOS: 117
SEQ ID NO 12
LENGTH: 633
TYPE: PRT
ORGANISM: Drosophila virilis
Query Match 100.0%; Score 3456; Length 633;
Best Local Similarity 100.0%;
Matches 616; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy
1 RPEPPVNSYLPPSPGDSYGAPGQGQGQGQGGFGGKPSDSYGAPGAGNGNGNGRPSSSYGA 60
Db
18 RPEPPVNSYLPPSPGDSYGAPGQGQGQGQGGFGGKPSDSYGAPGAGNGNGNGRPSSSYGA 77
Qy
61 PGQGQGQGGFGGKPSDSYGAPGAGNGNGNGRPSSSYGAPGQGQGQGGFGGRPSSSYGAPG 120
Db
78 PGQGQGQGGFGGKPSDSYGAPGAGNGNGNGRPSSSYGAPGQGQGQGGFGGRPSSSYGAPG 137
Qy
121 QGQGGFGGKPSDTYGAPGAGNGNGRPSSSYGAPGQGQGGIGGKPSDSYGAPGAGNGNGNG 180
Db
138 QGQGGFGGKPSDTYGAPGAGNGNGRPSSSYGAPGQGQGGIGGKPSDSYGAPGAGNGNGNG 197
Qy
181 RPSSSYGAPGQGQGGFGGKPSDTYGAPGAGNGNGRPSSSYGAPGQGQGGFGGKPSDTYGA 240
Db
198 RPSSSYGAPGQGQGGFGGKPSDTYGAPGAGNGNGRPSSSYGAPGQGQGGFGGKPSDTYGA 257
Qy
241 PGAGNGNGNGRPSSSYGAPGQGQGGFGGKPSDTYGAPGAGNGNGRPSSSYGAPGQGQGQG 300
Db
258 PGAGNGNGNGRPSSSYGAPGQGQGGFGGKPSDTYGAPGAGNGNGRPSSSYGAPGQGQGQG 317
Qy
301 GFGGKPSDSYGPPASGAGAGGAGGPGAGGGGDYDNDEPAKYEFNYQVEDAPSGLSFGHSE 360
Db
318 GFGGKPSDSYGPPASGAGAGGAGGPGAGGGGDYDNDEPAKYEFNYQVEDAPSGLSFGHSE 377
Qy
361 MRDGDFTTGQYNVLLPDGRKQIVEYEADQQGYRPQVRYEGDANGNGGPGGAGGPGGQDLG 420
Db
378 MRDGDFTTGQYNVLLPDGRKQIVEYEADQQGYRPQVRYEGDANGNGGPGGAGGPGGQDLG 437
Qy
421 QNGYSSGRPGGQDLGQGGYSNGRPGGQDLGQNGYSGGRPGGQDLGQNGYSGGRPGGQDLG 480
Db
438 QNGYSSGRPGGQDLGQGGYSNGRPGGQDLGQNGYSGGRPGGQDLGQNGYSGGRPGGQDLG 497
Qy
481 QNGYSGGRPGGQDLGQNGYSGGRPGGQDLGQNGYSGGRPGGQDLGQNGYSGGRPGGNGGS 540
Db
498 QNGYSGGRPGGQDLGQNGYSGGRPGGQDLGQNGYSGGRPGGQDLGQNGYSGGRPGGNGGS 557
Qy
541 DGGRVIIGGRVIGQDGGDGQGYSSGRPNGQDGGFGQDNTDGRGYSSGKPGQGRNGNGNSF 600
Db
558 DGGRVIIGGRVIGQDGGDGQGYSSGRPNGQDGGFGQDNTDGRGYSSGKPGQGRNGNGNSF 617
Qy 601 GPGGQNGDNDGSGYRY 616
Db 618 GPGGQNGDNDGSGYRY 633
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 9:00-5:30 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, Anand Desai can be reached at 571-272-0947. 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.
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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