DETAILED ACTION
Applicant should note that this case has been transferred to a new examiner, Alexandra Nicole Isnor, and claims reconsidered herein.
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 .
Claim Status
Applicants’ amendments and arguments filed 12/08/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 2-4, 7, and 15-18 are canceled.
Claim 1 is amended.
Claims 1, 5-6, 8-14, and 19 are examined on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/17/2025 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Objections
Claims 11 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Interpretation
In regards to claim 1, as to the limitation of ‘is able to form a sealing plug in lung parenchymal tissue following administration by syringe’ it is noted that the instant claims are composition claims and future intended use, such as using the composition to form a sealing plug, is not given patentable weight. Thus any composition comprising continuous phase of non-crosslinked biodegradable hyaluronic acid gel, and a dispersed phase of dehydrothermally crosslinked micron-sized gelatin hydrogel particles in which the dehydrothermally crosslinked micro-sized gelatin hydrogel particles have an average dimension of 20 to 50 microns prior to hydration will meet this limitation.
In regards to claims 5-6 and 14, as to the limitations of possesses or exhibits “an in vivo degradation period in the lung tissue of at least 2 weeks” and “in which the dehydrothermally crosslinked micron-sized gelatin hydrogel particles have an in-vivo degradation period in the lung tissue of less than 2 months”, it is noted that the instant claims are composition claims and future intended use, such as using the composition in the lung tissue, is not given patentable weight. Thus any composition comprising continuous phase of non-crosslinked biodegradable hyaluronic acid gel, and a dispersed phase of dehydrothermally crosslinked micron-sized gelatin hydrogel particles in which the dehydrothermally crosslinked micro-sized gelatin hydrogel particles have an average dimension of 20 to 50 microns prior to hydration will meet this limitation.
Claim Rejections - 35 USC § 112(d)
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 12 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. In the instant case, claim 12 recites the same limitations as claim 1 from which it relies and fails to add any additional claim limitations. 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.
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, 5-6, 8-10, and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-10, and 12-14 of U.S. Patent No. 11413023B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
US11413023B2 claims a system for sealing a channel in lung tissue comprising a medical device comprising a hydrogel delivery needle with a hydrogel in which the hydrogel is a viscoelastic shear-thinning hydrogel (claim 1; according to the claim limitations of the instant claim 1). Further, US11413023B2 claims the injectable viscoelastic shear-thinning hydrogel exhibits a storage modulus (G′) of at least 400 Pa in dynamic viscoelasticity measured by a rheometer at 1 Hz and 1% strain rate at 25° C (claim 1; according to the claim limitations of the instant claim 1). Claim 2 of US11413023B2 claims the injectable viscoelastic shear-thinning hydrogel exhibits a tan δ (G″/G′) from 0.1 to 0.8 in dynamic viscoelasticity measured by a rheometer at 1 Hz and 1% strain rate at 25° C. (according to the claim limitations of the instant claim 1). Claim 3 of US11413023B2 claims the injectable viscoelastic shear-thinning hydrogel exhibits a compressive modulus of greater than that of the lung tissue (according to the claim limitations of the instant claims 1, 8, and 12). Claim 4 of US11413023B2 claims the shear thinning viscoelastic hydrogel is configured to exhibit an in-vivo residence time of at least 1 week (according to the claim limitations of the instant claims 5-6 and 14). Claim 6 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising a continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles (according to the claim limitations of the instant claims 1 and 12-14). Claim 7 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles, and in which the micron-sized insoluble polymer particles have an average dimension of less than 100 microns (according to the claim limitations of the instant claims 1 and 12-14). Claim 8 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles, in which the continuous phase polymer comprises hyaluronic acid (HA) or a salt thereof (according to the claim limitations of the instant claims 1 and 12-14). Claim 9 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles, and in which the micron-sized insoluble polymer particles are formed of crosslinked gelatin (according to the claim limitations of the instant claims 1 and 12-14). Claim 10 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles, and in which the viscoelastic hydrogel comprises 2-20% micron-sized insoluble polymer particles (w/v) (according to the claim limitations of the instant claims 1, 9-10, and 12-14). Claim 12 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles, in which the continuous phase polymer comprises hyaluronic acid (HA) or a salt thereof, and in which the HA or salt thereof is not crosslinked and the micron-sized insoluble polymer particles are dehydrothermally crosslinked (according to the claim limitations of the instant claims 1 and 12-14). Claim 13 of US11413023B2 claims the viscoelastic hydrogel comprises a continuous phase comprising continuous phase polymer and a dispersed phase comprising micron-sized insoluble polymer particles, in which micron-sized insoluble polymer particles are crosslinked gelatin particles (according to the claim limitations of the instant claims 1 and 12-14). Claim 14 of US11413023B2 claims the system further comprises a syringe configured for fluidic connection to the hydrogel delivery needle, and in which the viscoelastic hydrogel is provided in the syringe (according to the claim limitations of the instant claims 1, 8, and 12-14).
US11413023B2 does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of US11413023B2with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611
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