DETAILED ACTION
Claims 1-27 are pending. Of these, claims 6, 9, 11, and 20-27 are withdrawn as directed to a nonelected invention. Therefore, claims 1-5, 7-8, 10, and 12-19 are under consideration on the merits.
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/Restriction
Applicant’s election of Group I, claims 1-19, is acknowledged. Since Applicant did not point to any alleged deficiencies in the restriction requirement, the election has been treated as having been made without traverse. The restriction requirement is still considered proper and is made FINAL.
Applicant’s election of a polymer having the sequence of EPR011 of Example 1 comprising SEQ ID NO:11, and a combination of freeze drying and washing with an organic liquid as the species of engineering method, is acknowledged. Since Applicant did not point to any alleged deficiencies in the election of species requirement, the election has been treated as having been made without traverse. The election of species requirement is still considered proper and is made FINAL.
Although Applicant states that claims 1-8, 10, and 12-19 read on both the elected invention and the elected species, claim 6 is directed to a combination of freeze drying and thermal exposure as the engineering method, while Applicant elected a combination of freeze drying and washing with an organic liquid as the species of engineering method. Therefore, claim 6 is withdrawn as directed to a nonelected species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/21/24 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Notice of Subject Matter Free of the Prior Art
Claims 1-5, 7-8, 10, and 12-19 as limited to the elected species of synthetic biopolymer are free of the prior art. An ABSS sequence search was conducted on the elected species comprising SEQ ID NO:11 as recited by claim 13, and uncovered no prior art teaching or suggesting a biopolymer comprising the elected species, i.e., comprising SEQ ID NO:11.
Search and examination was then expanded to include a synthetic biopolymer comprising the sequence of SEQ ID NO:12 as is also recited by claim 13, and again the ABSS search results did not uncover any prior art teaching or suggesting a biopolymer comprising this sequence. Therefore, claim 13 is free of the prior art over the full scope of the claim.
Examiner has now selected a polypeptide within the scope of claim 7 comprising SEQ ID NO:1, SEQ ID NO:2, and SEQ ID NO:3 as the next species under examination, and prior art was found against this sequence as discussed in the 103 rejection, infra.
Claim Objection
Claim 13 is objected to as depending from a rejected base claim, but would be in condition for allowance if rewritten in independent form and including all limitations of its base claim and any intervening claim.
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.
Claims 1-5, 7-8, 10, and 12-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 1 recites sub-ambient (e.g., 4 degrees Celsius), which is indefinite, because the use of the exemplary term “e.g.” makes it unclear whether the recited temperature is an actual limitation of the claim. Clarification is required. Since dependent claims 2-5 do not clarify the point of confusion, they are also rejected.
Claim 15 recites “or said synthetic ELP” in line 4 and again in line 7, which is indefinite because the preamble of the claim has been amended to delete reference to a synthetic ELP. Clarification is required.
Similarly, claim 17 recites “or said synthetic ELP” in line 4 and again in line 7, which is indefinite because the preamble of the claim has been amended to delete reference to a synthetic ELP. Clarification is required.
Similarly, claim 19 recites “or the synthetic ELP” in line 2 which is indefinite because claim 18, from which claim 19 depends, has been amended to delete reference to a synthetic ELP. Clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 recites that the synthetic ELP is engineered to undergo gelation following heating of a solution of the ELP at a sub-ambient or ambient temperature to a physiological temperature, but this limitation is already present in base claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 7-8, 10, 12, and 14-19 are rejected under 35 U.S.C. 103 as unpatentable over Ghandehari et al. (US Pat. Pub. 2018/0353522; of record in IDS) in view of Nagapudi et al. (Biomaterials 26 (2005) 4695-4706).
As to claims 1-5, 7-8, 10, 12, and 14-19, Ghandehan discloses compositions comprising a synthetic silk-elastin-like protein polymer, “SELP” (a “synthetic biopolymer “ as recited by claim 1 and a “synthetic elastin-like polypeptide (ELP)” as recited by claim 7), the protein polymer comprising repeating blocks of amino acids including silk blocks and elastin blocks (paragraphs 10 and 38), wherein the repeating elastin block may comprise the sequence VPGVG (a “hydrophobic block” of claim 7 wherein X is V as recited by claim 8), and the repeating silk block may comprise the sequence GAGAGS (a “beta-sheet formation-inducing block” of claims 7 and 12)(see paragraph 39, e.g., SEQ ID NO: 1). Ghandehan expressly teaches, however, that the sequences of the SELP are not limited to the examples taught therein (paragraph 39). The SELP protein polymer can be in the form of aqueous solutions (claim 18), but which convert to a hydrogel upon administration to a subject (paragraphs 10 and 52), meaning that they are engineered such that they would undergo gelation following heating of a solution of the synthetic biopolymer at ambient temperature to physiological temperature as recited by claims 1 and 14, and wherein the gelation involves physical crosslinking as recited by claim 1 (paragraphs 32, 79, 90) and wherein formation of beta-sheets is induced as recited by claims 1-2 (paragraph 95-96). Ghandehan further teaches flash freezing the composition followed by lyophilization (i.e., freeze-drying of claim 3)(paragraph 80).
Regarding claim 19, Ghandehan teaches lyophilizing the composition (see, e.g., paragraph 80), which will result in a porous solid form that is considered a “sponge” as recited by the claim.
As to claims 1-5, 7-8, 10, 12, and 14-19, Ghandehan does not further expressly disclose that the synthetic elastin like polypeptide comprises one or more aggregation-enhancing blocks of IPAVG (SEQ ID NO:2) as recited by claims 7 and 12 so as to read on the species of synthetic biopolymer currently under examination and which is present as an endblock as recited by claim 12, or that the biopolymer is engineered by a combination of freeze-drying and washing with an organic liquid (which is the elected species of claim 3), and wherein the washing is with one of the organic liquids recited by claim 4 such as one of the alcohols recited by claim 5, or that the aqueous solution comprises the properties recited by claims 15 and 17 and wherein the gelation is defined by the rheological properties obtained after the heating steps recited by claims 15 and 17 and wherein the gelation is irreversibile as recited by claims 16-17. Nor does Ghandehan expressly disclose the molecular weight of the synthetic biopolymer as recited by claim 10.
Nagapudi discloses the generation of elastin-mimetic protein triblock copolymers comprising identical endblocks comprises the hydrophobic plastic monomer sequence [(IPAVG)4(VPAVG)]n, and teaches that this endblock was chosen such that its inverse temperature transition would reside at or near ambient temperature, resulting in phase separation of the hydrophobic domains from aqueous solution under physiological temperature and pH (paragraph bridging pages 4695-4696). Nagapudi further teaches that various factors affect the strain level above which the viscoelastic response becomes nonlinear, including the molecular weight of the polymer (paragraph bridging left and right columns of page 4700).
As to claims 1-5, 7-8, 10, 12, and 14-19, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the elastin-like synthetic biopolymer of Ghandehan by incorporating endblocks comprising (IPAVG)4, because Nagapudi teaches that certain sequences comprising (IPAVG)4 are useful as endblocks in elastin-like proteins because they result in an inverse phase temperature transition that is at or near ambient temperature, resulting in phase separation of the hydrophobic domains from aqueous solution under physiological temperature and pH, such that the skilled artisan reasonably would have expected that incorporating the Nagapudi endblocks into the elastin-like synthetic biopolymer of Ghandehan would aid in converting the synthetic biopolymer into a hydrogel upon administration of a composition comprising the synthetic biopolymer to a subject as taught by Ghandehan. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
The resulting synthetic biopolymer will undergo gelation following heating of a solution of the biopolymer as recited by claim 1 wherein the solution is an aqueous solution having the properties of claims 15 and 17 and wherein gelation is as defined by claim 15, and wherein the gelation will be “irreversible” as recited by claims 16-17 because it comprises the same structure recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Regarding claims 3-5, the Office notes that these claims are written in the form of product by process claims, such that their patentability is determined by the structure of the claimed composition and not by the steps by which the composition is made. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ, does not change the end product.).
Here, the composition of Ghandehan and Nagapudi as combined supra comprises the same synthetic biopolymer recited by the claims and Ghandehan expressly teaches that the biopolymer gelates upon heating to physiological temperature and undergoes beta-sheet formation as recited by the claims, and therefore reads on the recitation that the biopolymer is engineered to undergo gelation following heating as recited by the claims regardless of whether the induction is engineered by the specific process steps recited by claims 3-5.
As to claim 10, it further would have been prima facie obvious to select a molecular weight of the synthetic elastin like polypeptide that is within the claimed range, because said weight is a result effective variable that will influence the viscoelastic response of the polymer as taught by Nagapudi, and with a reasonable expectation of success because the skilled artisan would have been optimizing the polymer for the same function, i.e., to perform as a mimetic of elastin. “[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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7-8, 10, 12, and 14-19 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 19/481,308, and in view of Nagapudi et al. (Biomaterials 26 (2005) 4695-4706).
where indicated below.
The teachings of the cited secondary reference is relied upon as discussed above.
The reference claims recite a synthetic biopolymer aqueous solution comprising the same sequences recited by present claims 7-8, the biopolymer being engineered to undergo gelation and undergo physical crosslinking resulting from beta-sheet formation following heating.
The composition of the reference claims will undergo gelation following heating of a solution of the biopolymer wherein the solution is an aqueous solution having the properties of claims 15 and 17 and wherein gelation is as defined by claim 15, and wherein the gelation will be “irreversible” as recited by claims 16-17 because it comprises the same structure recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Although the reference claims do not specify that the IPAVG sequence forms at least a portion of an endblock of the biopolymer as recited by present claim 12, it would have been prima facie obvious to place it there in light of Nagapudi’s teaching that certain sequences comprising (IPAVG)4 are useful as endblocks in elastin-like proteins because they result in an inverse phase temperature transition that is at or near ambient temperature, resulting in phase separation of the hydrophobic domains from aqueous solution under physiological temperature and pH.
Although the reference claims do not specify the molecular weight of the biopolymer, it would have been prima facie obvious to select a molecular weight of the synthetic elastin like polypeptide that is within the claimed range, because said weight is a result effective variable that will influence the viscoelastic response of the polymer as taught by Nagapudi, and with a reasonable expectation of success because the skilled artisan would have been optimizing the polymer for the same function, i.e., to perform as a mimetic of elastin. “[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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The synthetic biopolymer of the reference claims will undergo gelation following heating of a solution of the biopolymer as recited by claim 1 wherein the solution is an aqueous solution having the properties of claims 15 and 17 and wherein gelation is as defined by claim 15, and wherein the gelation will be “irreversible” as recited by claims 16-17 because it comprises the same structure recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Regarding claims 3-5, the Office notes that these claims are written in the form of product by process claims, such that their patentability is determined by the structure of the claimed composition and not by the steps by which the composition is made. The reference composition comprises the same synthetic biopolymer recited by the claims and therefore reads on the recitation that the biopolymer is engineered to undergo gelation following heating as recited by the claims regardless of whether the induction is engineered by the specific process steps recited by claims 3-5. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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