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 .
Withdrawn Rejections
The prior rejection of claims 1-7 under 112(a) Written Description is withdrawn based on Applicant’s claim amendments to specify structural properties of the sheet-like material such as pressed, total amount of alginate and total amount of calcium chloride.
Examiner’s Note
Applicant's amendments and arguments filed 11/24/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 11/24/2025, it is noted that claim 1 has have been amended and no new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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.
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 but at not deemed to be persuasive.
Applicant argues the adhesion preventing material described in the examples of the ‘260 publication contains approximately 0.28 mg/cm2 of calcium chloride as the curing agent, calculated based on [0144]. The amounts give are about 1.0 umol/cm2 for the upper layer and about 1.5 ug/cm2 for the lower layer and this is not anticipated.
In response, the rejection has been modified based on Applicant’s claim amendments to obviousness. The about language allows for amounts above and below the specifically recited amount and thus reads on the instant claims. 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].
Applicant argues the functional features defined in claim 1 are beyond the scope of routine experimentation and would not have been obvious a person skilled in the art. The specification explains that especially in pressed adhesion preventing materials, satisfying requirement (1) in addition to requirements (2) is an important factor for in vivo application. The Applicant did not merely adjust dissolution rate of the adhesion preventing material by changing the molecular weight of alginate or type or concentration of the crosslinking agent. Rather Applicant pursued an adhesion preventing material more suitable for in vivo use and conceived the claimed invention by optimizing both the conditions required for such use and the evaluation method (test method) necessary for satisfying these conditions. In the ‘260 publication there is not specific suggestion regarding what dissolution rate or water absorption properties should be achieved for the adhesion preventing material, thus it would not have been obvious to modify the material of the ‘260 publication to a person of ordinary skill in the art to arrive at the presently claimed invention.
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 is referred to the modified rejection above wherein the structural features of pressing, total amount of alginate and total amount of curing agent are taught by the ‘260 publication. The ‘260 publication teaches the total amount in the upper and lower layer of sodium alginate was 2.0 mg/cm2, the calcium chloride was about 0.28 mg/cm2 of calcium chloride and the sponges were pressed ([0144], [0054]). Thus the structural features overlapping with the instant claims is taught by the ‘260 publication.
Double Patenting:
Applicant argues based on the above amendments withdraw of the rejection is required.
In response, Applicant is referred to the modified rejections above based on Applicant’s claim amendment.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613