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 election of B: branched PEG oligomer MW <5000, L: urea bond, L’: urethane bond, A: methyl hexanoate, W: 4-alkylbenzene-1,2-diol derivative, m:1, n:1, not crosslinked in the reply filed on 3/24/26 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 § 818.01(a)).
Claims 3, 5, 6, 7, 10, 16, 27, 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/species, there being no allowable generic or linking claim.
Priority
The claims have an effective date of the foreign priority (which is in English): 12/20/19
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/14/22 has been considered by the examiner.
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 9, 11, and their dependents, 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.
Regarding claims 9 and 11, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 8, 9, 11, 12, 14, 18, 20, 21, 31 is/are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wells (WO 2014138190-reference of record).
Wells discloses in Fig 1B the following compound:
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The above W, L, A, L’ and B meet instant claim 1 wherein B has a MW of approx. 350 (about 8 PEG repeats * 44 g/mol = 352) and A is derived from the elected methyl hexanoate. Therein M=1 and n=0.
As shown in Fig 1B this is then crosslinked to form a gel. Since the adhesive endgroups are met, even in polymerized/crosslinked form, one would expect some degree of adhesiveness to the gel composition (note claim 1 also discloses crosslinked polymers using the above agent). There are no adhesive strength limitations nor materials to which it must be capable of adhering to. The composition of Wells is used as a gel cell matrix (abstract) for aiding in tissue growth and must be some what adhesive to what it is applied onto, otherwise it would not be suitable to aid in wound healing. Further, since the composition requirements are met, and, the composition must be pliable at room temperature for its intended use, the Tg requirements are expected to be anticipated by Wells. Alternatively, the reference is expected to embrace such, rendering the Tg prima facie obvious. If there is any difference between the product of the reference and the product of the instant claims the difference would have been minor and obvious. "Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01(I) , In re Best, 562 F2d at 1255, 195 USPQ at 433, Titanium Metals Corp v Banner, 778 F2d 775, 227 USPQ 773 (Fed Cir 1985), In re Ludtke, 441 F2d 660, 169 USPQ 563 (CCPA 1971) and Northam Warren Corp v D F Newfield Co, 7 F Supp 773, 22 USPQ 313 (EDNY 1934).
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 USC 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 USC 103 and for anticipation under 35 USC 102." See MPEP 2112(III) and In re Best, 562 F2d at 1255, 195 USPQ at 433.
Elements above meet claim 1. Likewise the Tm of claim 8 is deemed to be anticipated, since the structure of claim 1 is met, or embraced and prima facie obvious. Elements above meet claims 9, 11, 12, 14. Applicant has not explicitly disclosed what materially affects the basic and novel characteristics of the invention, thus consisting essentially of, of claim 18, is treated as comprising. Elements above thusly meet it. For reasons set forth above, those properties of claims 20 and 21 are met. Claim 31 is a product by process limitation, the process of making is not pertinent unless Applicant shows a distinct product is produced. The same compound is produced as instantly elected, thus claim 31 is met.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells in view of Dalsin (US 8916652).
Wells includes elements as set forth above. Wells discloses gel matrixes for tissue repair. Wells discloses wherein B may be linear PEG but does not disclose branched PEG (which would also result in an additional pendent adhesive group thereon when further reacted with A and W moieties)
Dalsin discloses multi-arm catechol compounds (title). See Fig 1, page 3 where the following compound is disclosed:
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Therein, the center PEG of the compound is a branched PEG, attached to the catchol via a urethane L’ linkage. This is the same L’ linkage that the PEG is linked to in Wells (thus akin to Wells) and has the same end W groups (thus also akin to Wells). Column 14 lines 61-66 discloses wherein the composition is used for hydrogels, thus akin to Wells. Dalsin thusly disclosed suitably known other PEG molecules that may be used to form similar compounds for similar uses as Wells.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include in Wells the use of branched PEG, as taught by Dalsin, since it is recognized in the art to be a suitably known center PEG compound for catchol-endgroup containing gel-forming materials. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), wherein the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination.
Elements above meet claim 4.
Claim(s) 1, 8, 9, 11, 14, 18, 20, 21, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kontra (WO 2017044896-reference of record).
Kontra discloses polymer materials suitable for adhesives (title) that may comprise the compound of Figure 13:
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This compound meets the elected species EXCEPT that A is hexamethylene diisocyanate (not the elected methyl hexanoate), and, PEG has n=226, which calculates to about 10k MW which does not meet B of claim 1.
Kontra discloses in [051] that n of PEG may range from 4-25000. This embraces the MW of B of claims 1 and 9 (e.g. n=4 calculates to MW of (4*44) about 176). Further, hexamethylene diisocyante (MW 168) meets the A of claim 1 (though not the elected species). Since the MW is embraced, and, the structure is very similar to that of Applicants, the Tm (of claim 1) and Tg (of claim 8) is deemed to be embraced by the reference.
Elements above, in light of the overlapping range of the n repeat unit for PEG, embrace and render prima facie obvious claims 1, 8, 9, 11, 14. Applicant has not disclosed what materially affects the basic and novel properties of the composition, so consisting essentially of in claim 18 is treated as comprising, thus claim 18 is met by the composition of Kontra. The composition is expelled from a syringe (Fig 3) one would desire to do such at room temperature, thus claim 20 must be embraced by the reference. Since the composition requirements are met the properties of claim 21 are deemed to be embraced. Claim 31 is drawn to the process of making, such is not pertinent unless Applicant shows a distinct product is produced. Kontra meets the claimed structure and thus meets claim 31.
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, 8, 9, 11, 14, 18, 20 21, 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12239758. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘758 discloses a structure with Blocks W-L-A-L’-B-L’-A-L-W including a branch from block B, wherein the compound has a Tg lower than 25C. This meets instant claims 1, 8, 9, 11, 14, 18, 20, 21, 31 wherein properties of the instant claims are deemed to be embraced by the structure disclosed in claim 1 of ‘758.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. EP2334305 (ref of record), US 11384260 and US 20120029559 are cited as close prior art. US ‘260 does not qualify as prior art and EP ‘305 and US ‘559 disclose similar structures but said structures do not meet the requirements of claim 1.
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/ALICIA BLAND/ Primary Examiner, Art Unit 1759
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