DETAILED ACTION
Claims 1-2, 5, 7-12 are currently pending. Claims 1-2, 5 and 7 are currently under examination.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/13/2026 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 02/13/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 02/13/2026, it is noted that claim 1 has have been amended and no new matter or claims have been added.
New Rejection:
The following rejection is newly applied.
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 1-2, 5 and 7 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.
Claim 1 contains the limitation “at least a portion of”. It is unclear what “portion” is being referred to, is it a portion of the material, a portion of the alginate? The instant claims are unclear as to what “at least a portion of” is referring back to and thus has unclear metes and bounds.
Modified Rejections:
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.
Claim(s) 1-2, 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0209260 (Applicant provided).
Regarding claim 1, the limitation of a sheet-like material for preventing adhesion which contains alginate, at least a portion of which is crosslinked with curing agent is met by the ‘260 publication teaching an adhesion preventing material having a high adhesion preventing effect comprising a biocompatible sponge like laminate wherein the sponge-like laminate comprises a sponge-like first layer and a sponge like second layer which is at least partially crosslinked with a curing agent comprising alginic acid (abstract) specifically alginate [0015] and the curing agent such as CaCl2 (claim 7).
Regarding the limitation of a total amount of the alginate is 1.4 mg/cm2 or more and 2.8 mg/cm2 or less in terms of weight of sodium alginate is met by the ‘260 publication teaching metal salts of alginic acid being 1.8 mg/cm2-2.2 mg/cm2 [0069] specifically sodium alginate [0068].
Regarding the limitation of the curing agent is a calcium ion compound and a total amount of calcium is 0.14 mg/cm2 or more and 0.30 mg/cm2 or less in terms of a weight of calcium chloride is met by the ‘260 publication teaching the curing agent is CaCl2 [0015] wherein the calcium chloride was about 1.0 umol/cm2 and about 1.4 umol/cm2 [0144], which leads to 0.112 mg/cm2 and 0.155 mg/cm2 and a total of 0.267 mg/cm2. Additionally, the ‘260 publication teaches a range of the curing agent of 0.1-100 umol/cm2 for each of the upper and lower layers, thus an optimizable range based on the suitable according to the molecular weight of the alginic acid used [0076]. As MPEP 2144.05 recites “where 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 optimization”.
Regarding the limitation of wherein the sheet-like material for preventing adhesion has been pressed is met by the ‘260 publication teaching the laminate is pressed [0054].
Regarding claim 2, the limitation of a first and second layer is met by the ‘260 publication teaching a first and second layer (claims 1).
Regarding claim 5, the limitation of the curing agent is a thickness of the sheet-like material for preventing adhesion is 100 um or more and 500 um or less is met by the ‘260 publication teaching 0.2 mm to 30 mm [0052] which is 200 to 30,000 um.
Regarding claim 7, the limitation of wherein a dissolution rate of the first layer is slower than that of the second layer is met by the ‘260 publication teaching dissolution of the first layer is slower than that of the second layer [0015].
The ‘260 publication does not specifically teach the material preventing adhesion satisfying (1) and (2) when a dissolution test is performed in which a sample cut into a substantial circle having a diameter of 8mm is left to stand, via a mesh, on agar of a petri dish which a physiological saline solution is added substantially to a top surface of the agar having the specific dissolution time and maximum weight time is met by the ‘260 publication teaching the structural features of the claim as addressed above by the ‘260 publication. The ‘260 publication teaches sponge-like laminate which is at least partially crosslinked with a curing agent and comprising alginic acid (abstract). “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and Applicant’s own disclose supports the suitability of the prior composition as the inventive composition component, the burden is property shifted to Applicant to show otherwise.
It would have been obvious to optimize the sheet-like material to obtain the desired functional properties as the ‘260 publication teaches the first and second layer having different dissolution rates in the sponge like laminate wherein the partial crosslinking is taught and the first and second layer are taught to have different dissolutions rates [0015], wherein molecular weight is taught as a mechanism to change the dissolution rate [0045], thus indicating an optimizable parameter. As MPEP 2144.05 recites “where 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 optimization”.
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 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,464,597. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘597 patent teaches an adhesion preventing material comprising metal salts of alginic acid and calcium chloride comprising a two-layer sheet which is pressed during formation and contain overlapping concentrations of alginate. Regarding the dissolution limitations, “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).As MPEP 2144.05 recites “where 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 optimization”.
Claims 1-2 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,890,145. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘145 patent teaches an adhesion preventing material comprising metal salts of alginic acid and calcium chloride comprising a two-layer sheet which is pressed during formation and contain overlapping concentrations of alginate. Regarding the dissolution limitations, “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As MPEP 2144.05 recites “where 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 optimization”.
Claims 1-2, 5 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/903,674 (reference application) in view of US 2019/0209260. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘674 application teaches an adhesion preventing material comprising metal salts of alginic acid and calcium chloride comprising a two-layer sheet which is pressed during formation and contain overlapping concentrations of alginate. Regarding the dissolution limitations, “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The ‘674 application does not specifically teach the thickness of the alginate sheet. The ‘260 publication teaches an alginate sheet cured with calcium chloride wherein the thickness of the sheet is 0.02-3mm (abstract, [0015], [0054]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known thickness of pressed alginate cured CaCl sheet as the ‘260 publication teaches a range of known thickness of alginate CaCl sheets, thus rendering it obvious to use known sheet thickness for sheets made of the same material by the same pressing processing steps as taught by the ‘260 publication.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103:
Applicant argues the office asserts that the “about” language allows for amounts above and below the specifically recited amount and further cites [0076] of the ‘260 publication. Applicant argues the 0.1-100 umol/cm2 is broad and generalized range. It does not provide any teaching or suggestion to select the presently claimed specific range, much less a narrower range of 0.14 mg/cm2 to 0.27 mg/cm2 in terms of calcium chloride. A person of ordinary skill in the art would not have been guided from such a broad range to specifically choose the presently claimed range with an upper limit of 0.27 mg/cm2, at least because lowering the amount of curing agent toward the lower end could reasonably raise concerns that resulting compositions might not be sufficiently crosslinked and therefore might not provide adequate adhesion. The exemplified amount of approximately 0.28 mg/cm2 or any of the many other values encompassed by the broad disclosure.
In response, the ‘260 publication teaching the curing agent is CaCl2 [0015] wherein the calcium chloride was about 1.0 umol/cm2 and about 1.4 umol/cm2 [0144], which leads to 0.112 mg/cm2 and 0.155 mg/cm2 and a total of 0.267 mg/cm2. Additionally, the ‘260 publication teaches a range of the curing agent of 0.1-100 umol/cm2 for each of the upper and lower layers, thus an optimizable range based on the suitable according to the molecular weight of the alginic acid used [0076]. As MPEP 2144.05 recites “where 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 optimization”. It is noted that the ‘260 publication uses about language regarding the amounts of calcium chloride used, thus allowed for amounts above and below the specifically recited range, discloses broad ranges for the calcium chloride thus allowing for optimization. Additionally, the ‘260 publication is not only as good as the specifically exemplified examples, but rather the broader teachings as well. “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (see MPEP 2123). Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (see MPEP 2141.02).
Applicant argues the functional limitations of (1) and (2) are not matters of routine optimization suggested by the ‘260 publication. The present application did not merely adjust dissolution rate by varying molecular weight of alginate or type/concentration of crosslinking agent, rather balance of properties suitable for in vivo application. The ‘260 publication does not teach the claimed chemical structure, thus the rational of inherency does not apply.
In response it is noted that that instant claims are directed to product claims, thus the limitations are directed to the structure of the sheet-like material will have the functional properties if subjected to the testing steps. The specific dissolution testing steps are not required. The ‘260 publication does not specifically teach the material preventing adhesion satisfying (1) and (2) when a dissolution test is performed in which a sample cut into a substantial circle having a diameter of 8mm is left to stand, via a mesh, on agar of a petri dish which a physiological saline solution is added substantially to a top surface of the agar having the specific dissolution time and maximum weight time is met by the ‘260 publication teaching the structural features of the claim as addressed above by the ‘260 publication. The ‘260 publication teaches sponge-like laminate which is at least partially crosslinked with a curing agent and comprising alginic acid (abstract). “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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and Applicant’s own disclose supports the suitability of the prior composition as the inventive composition component, the burden is property shifted to Applicant to show otherwise.
Applicant argues the effectiveness of the present invention has been confirmed not only in rat model but also in a mini-pig model, which provides meaningfully evidence of practical anti-adhesion performance. Comparative examples has CaCl2 content of 0.31 mg/cm2 which is only slightly above the amended upper limit of 0.27 mg/cm2. Comparative Example 1 shows that even a relatively small increase in calcium content beyond the presently claimed range can lead to loss of the desirable anti-adhesion performance in the mini pig model. Applicant points to Example 1 and 4, which fall within the claimed range (Fig 22 and 23).
In response, Applicant point to the instant specification to demonstrate unexpected results. The results presented are not commensurate in scope with the instant claims. Applicant points to examples 1 and 4 in comparison to Comparative Example 1. It is noted however that the examples are directed to specific amounts of calcium and alginate wherein there is an upper range and lower range in a specific ratio. The instant claims are more broadly directed to a range of alginate and calcium wherein layer and specific ratios in the layers are not taught. It is further noted that Example 1 is directed to 18 mg/72cm2 and comparative example 3 is directed to 18 mg/72 cm2, wherein the results are different in solubility, thus demonstration that not only the calcium amount, but the layering and ratio results in different results, wherein both fall with the recited claim. Additionally, the ‘260 publication teaching the curing agent is CaCl2 [0015] wherein the calcium chloride was about 1.0 umol/cm2 and about 1.4 umol/cm2 [0144], which leads to 0.112 mg/cm2 and 0.155 mg/cm2 and a total of 0.267 mg/cm2. Applicant is presenting evidence wherein 0.31 mg/cm2 does not provide the desired adhesion, however the amounts disclosed in the ‘260 publication are below 0.31 mg/cm2.
Double Patenting:
Applicant argues based on the 103 above the rejection is withdrawn.
Applicant’s arguments regarding the 103 rejection are addressed above as first presented. Applicant has presented no specific arguments regarding the double patenting rejections thus they are maintained for reasons of record.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
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