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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim Status
Applicant’s preliminary amendment of 02/06/2025 is acknowledged. Claims 43-44, 46, 48-50, 54-56, 58-61, 65-67, 69, 77, and 85 are amended; claims 1-42, 45, 47, 51-53, 57, 62-64, 68, 70-76, 78-84, and 86-92 are cancelled; and claim 93 is new. Claims 43-44, 46, 48-50, 54-56, 58-61, 65-67, 69, 77, 85, and 93 are currently pending.
Priority
The instant application is a 371 of PCT/US2022/037397 filed on 07/15/2022 and claims domestic benefit to U.S. Application No. 63/222,394 filed on 07/15/2021 as reflected in the filing receipt dated on 02/26/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/16/2024 and 02/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Election/Restrictions
Applicant's election without traverse of Group I, claims 43-44, 46, 48, and 93, in the reply filed on 06/23/2026 is acknowledged. The restriction requirement dated 04/23/2026 states that the invention of Group I is a preservation composition, whereas the invention of Group II is a combination of a preservative composition and a biological sample. The inclusion of claim 48 in both Groups I and II was a typographical error, as the combination recited in claim 48 clearly belongs to Group II and was not meant to be in Group I. Accordingly, the Examiner clarifies that claim 48 belongs to Group II rather than Group I.
In response to the election of species request, Applicant elected Composition 9 of Table 1 in Applicant’s instant specification, which comprises 15 wt.% poloxamer p188, 15 wt.% poloxamer p407, and 2.5 wt.% EDTA. Because Applicant’s reply does not distinctly and specifically point out supposed errors in the species election requirement, the election is treated as an election without traverse.
In searching for the elected species shown above, art was found that reads on an additional species of claim 43 and, consequently, claim 93. The species election was extended to include compositions comprising 1.57 wt.% EDTA, and subsequently the art was applied in the instant office action to expedite prosecution.
Claims 43-44, 46, 48-50, 54-56, 58-61, 65-67, 69, 77, 85, and 93 are pending in the application. Claims 48-50, 54-56, 58-61, 65-67, 69, 77, and 85 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/23/2026. Accordingly, claims 43, 44, 46, and 93 are being examined on the merits herein.
Claim Objections
Claims 43, 44, and 93 are objected to because of the following informalities:
Claims 43, 44, and 93 recite the acronym “EDTA”, which is not defined in the claims. When an acronym is used in a claim set, it should be defined the first time it appears in the claims. For the purposes of examination, the term “EDTA” is interpreted to mean “ethylenediaminetetraacetic acid” as defined in Applicant’s instant specification [0029].
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 43, 44, 46, and 93 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.
Claims 43, 44, and 93 each recite the limitation “wt %”. It is unclear whether the term indicates total composition weight or component weight, etc. Therefore, the metes and bounds of the claim are indefinite. For the purpose of the prior art rejections below, the claim is interpreted to mean wt % based on the total weight of the composition. Claims 44, 46, and 93 are rejected by virtue of their dependency on claim 43, as they fail to resolve the ambiguity in question.
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 43, 44, 46, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Koller et al. (US20120207700A1; published: 08/16/2012; PTO-892 of 04/23/2026).
Koller teaches compositions comprising poloxamers as surface active agents, noting that poloxamer 188 and 407 are known to be biocompatible and non-toxic to mammalian cells and tissues, making them useful for biomedical applications, such as increasing oxygenation, reducing bacteria, and/or improving healing when administered at a tissue site [0004 and 0014]. Koller further teaches a specific formulation (Formulation P) comprising: 15% w/w poloxamer 188 and 0.8% w/w EDTA, among other ingredients [0268, table]. Koller specifically teaches that poloxamer 188 and 407 are both preferred poloxamers, noting that its compositions may comprise more than one poloxamer such that their total concentration falls within the range of from about 10% to about 40% w/w [0041-0046].
Regarding claims 43, 44, and 93: The amount of poloxamer 188 lies within and thus reads on the instantly claimed amount.
Regarding the amount of poloxamer 407, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Formulation P by further including an additional poloxamer, such as poloxamer 407, within the range of 10% to 25% w/w, which overlaps and thus renders obvious the instantly claimed amount (calculated by Examiner based on 10% to 40% w/w total poloxamer, minus the 15% w/w poloxamer 188 already present in the composition). An ordinarily skilled artisan would be motivated to include poloxamer 407 in order to optimize the ability of the composition to penetrate into and through materials, as taught by Koller [0125].
Regarding the amount of EDTA, it would have been prima facie obvious to further modify Formulation P by manipulating the amount of disodium EDTA within the prior art range of about 1-3% w/w, which overlaps and thus renders obvious the instantly claimed amount, in order to improve the shelf life of the composition [0026, 0207, and 0268, table].
Regarding claim 46: Koller expressly teaches that the formulation can be prepared as a liquid, wherein water is exemplified as a suitable solvent [0020 and 0268, table], which meets the limitation “aqueous solution”. Alternatively, Koller teaches that the formulation can be prepared as a dry powder [0223]. It is noted that the recitation “lyophilized dry powder” is directed to a product by process. The patentability of a product-by-process claim is based on the product itself and does not depend on its method of production.
Additionally, it is noted that the recitation “preservative” in claims 43, 44, 46, and 93 is an intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition of Koller is capable of performing the intended use when administered to a tissue site, as taught by the reference, then it meets the claim. Note: MPEP 2111.02.
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 43, 44, 46, and 93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15, 25-26, 29, 38, and 94-95 of copending Application No. 17/920,271 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a preservative composition comprising one or more of poloxamer p188 or poloxamer p407 in an amount which overlaps and thus renders obvious the instantly claimed concentrations [see copending claims 13, 25-26, and 38, for example], and the composition may further comprise EDTA as an enzyme inhibitor in an amount that overlaps and thus renders obvious the instantly claimed concentrations [see copending claims 25, 26, and 29, for example]. Because the composition is intended to form a hypertonic solution [see copending claims 13 and 25], it would have been prima facie obvious to one of ordinary skill in the art to formulate the composition as an aqueous solution, or a non-aqueous solution.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 43, 44, 46, and 93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9-15, 19-22, 26-33, and 37-38 of copending Application No. 19/108,660 (reference application) in view of Koller et al. (US20120207700A1; published: 08/16/2012; PTO-892 of 04/23/2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a preservative composition comprising each of poloxamer p188 and poloxamer p407 in an amount of 15% by weight of the composition [see copending claim 20, for example], and EDTA in an amount of about 1.5% to about 2.5% by weight of the composition [see copending claim 29, for example], which substantially reads on the instantly claimed concentrations.
The claims of App. ‘660 do not expressly recite the form of the composition as recited in instant claim 46.
The teachings of Koller are as set forth above and further incorporated herein.
Regarding claim 46: It would have been obvious to one of ordinary skill in the art to formulate the composition recited in the claims of App. ‘660 as an aqueous solution or a dry powder with a reasonable expectation of success because Koller teaches this is a suitable form for compositions comprising poloxamer 188 and 407 that is non-toxic to mammalian cells and tissues.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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