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 .
Note from Examiner
The art unit location of your Application at the USPTO has changed. To aide in correlating any papers for this application, all further correspondence regarding this application should be directed to Examiner Judith Kamm in Art Unit 1611.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a biodegradable, non-porous medical device in the reply filed on 06/25/2026 is acknowledged.
Claims 11-17 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/25/2026.
Claims 1-10 and 18-19 are under current examination.
Priority
This application is a national stage entry of PCT/EP2023/055892, filed 09/14/2023. Foreign
priority has been claimed to EP 22161125.4, filed 03/09/2022. Receipt is acknowledged of certified
copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/09/2024 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the
Examiner.
Claim Interpretation
The instant specification does not set forth a definition of the term “about”. Herein, the Examiner interprets that values modified by the term “about” are inclusive of that value ± 10%.
Claim Objections
Claim 5 is objected to because of the following informalities: the abbreviation “NHS” should be defined upon its first appearance in claim 5.
Appropriate correction is required.
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 1-10 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ericson (WO 2017/210267 A2, published December 7th, 2017; included on IDS submitted 08/09/2024) in view of Kageyama et al. (US 10,485,894 B2, patented November 26th, 2019), hereafter “Kageyama”, and Bordoloi et al. (US 2012/0288530 A1, published November 15, 2012), hereafter “Bordoloi”.
Regarding instant claim 1, Ericson teaches flexible plasma-based films useful as a hemostat (see entire document, particularly abstract) which may comprise several layers (claim 21). The film of Ericson can be described as a sheet (pg. 8, lines 11-13), and per the instant specification, a sheet-like structural layer is inclusive of a flexible plasma-based film (pg. 5, lines 11-13). The films of Ericson are taught to be fully biodegradable (pg. 26, lines 17-19). Ericson teaches that fibrinogen is topically applied onto the film (proximal to the structural layer), a separation layer comprising starch is applied, and thrombin is topically applied to the separation layer (distal to the structural layer) (claims 23-24). The fibrinogen, starch, and thrombin are taught to be applied to one side of the plasma-based films (see Example 1 at pg. 34-35 and Figure 3).
Per the instant specification, “the term “water-activatable adhesive component” means a multilayered component of the device of the present invention that mediates affixation of the medical device of the present invention to the site of injury, trauma or surgery, where the device is to be used as a hemostat. The layer most distant to the structural layer of the device is a thrombin layer. It is the thrombin layer that mediates the adhesive properties of the adhesive component when rehydrated by an aqueous solution such as blood…” (pg. 9, line 33-pg. 10, line 10). As noted above, the multilayered component of Ericson comprises a distal thrombin layer, and Ericson further teaches that hemostatic films are applied to a wound to stop bleeding, with thrombin and fibrinogen-containing films being the most effective to stop bleeding (see Example 1 at pg. 34-35). Thus, it is interpreted that the multilayered component of Ericson is consistent with the provided definition of “water-activatable adhesive component”.
Per the instant specification, “the term “non-porous”, in general refers to structures or devices that have such a low degree of porosity such that they do not allow for transmission of liquids such as water or blood through the structure or device itself. Therefore, such structures or devices can act at sealants to stem the immediate flow of such liquids…” (pg. 9, lines 3-11). The films of Ericson are taught to seal bleeds (pg. 11, lines 4-11) and are effective to stop bleeding (see Example 1 at pg. 34-35), and are thus interpreted as consistent with the provided definition of “non-porous”.
Regarding instant claim 2, as noted above, Ericson teaches flexible plasma-based films (see particularly abstract; and pg. 17, lines 14-21).
Regarding instant claim 3, Ericson teaches that the blood plasma is mixed with about 0.1 to 10 International Units (IU) of thrombin per milliliter (ml) (claims 9-11), the plasma film has a thickness ranging from about 0.005 to about 0.1 mm (claim 32), and that the film is characterized by a burst pressure of about 50 to about 1000 mm Hg (claim 35) (see also pg. 5, lines 9-23). Per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”
Instant claim 4 depends from instant claim 2, which requires a flexible plasma-based film or a flexible cryoprecipitate. As set forth above, Ericson meets the limitation of a flexible plasma-based film.
Regarding instant claim 7, Ericson teaches applying about 5 ml of a 300 IU/ml thrombin solution on a 4”x4” film (pg. 15, lines 9-18). Thus, Ericson teaches applying about 1500 IU (5 ml x 300 IU/ml) of thrombin per approximately 103.2 cm2 (1 in = 2.54 cm, 4 in = 10.16 cm, 16 in2 = 103.2 cm2), or about 14.5 IU per cm2, consistent with the range of “between about 15 and about 30” of the instant claims.
Regarding instant claim 9, per the instant specification (emphasis added), “the term “water-activatable adhesive component” means a multilayered component of the device of the present invention that mediates affixation of the medical device of the present invention to the site of injury, trauma or surgery, where the device is to be used as a hemostat. The layer most distant to the structural layer of the device is a thrombin layer. It is the thrombin layer that mediates the adhesive properties of the adhesive component when rehydrated by an aqueous solution such as blood…” (pg. 9, line 33-pg. 10, line 10). As noted above, the multilayered component of Ericson comprises a distal thrombin layer, and Ericson further teaches that hemostatic films are applied to a wound to stop bleeding, with thrombin and fibrinogen-containing films being the most effective to stop bleeding (see Example 1 at pg. 34-35). Thus, it is interpreted that the distal thrombin of the multilayered component of Ericson mediates fixation when placed at the site of a wound.
Regarding instant claim 10, Ericson teaches that the plasma-based films (side opposing the distal thrombin layer) can act as an anti-adhesive sheet to reduce or prevent development of surgery-induced adhesions (abstract; pg. 12, lines 1-17).
Regarding instant claim 18, as noted above, Ericson teaches applying about 14.5 IU thrombin per cm2 (pg. 15, lines 9-18), consistent with the range of “between about 15 and about 25” of the instant claim.
Ericson does not teach the inclusion of carboxymethyl cellulose (instant claim 1), nor the amounts of fibrinogen and CMC per cm2 of the structural layer recited in instant claims 8 and 19.
Kageyama teaches a formed sheet product comprising a polymer composition layer comprising fibrinogen and a water-soluble polymer and a second polymer layer comprising thrombin (see entire document, particularly Abstract and claim 1); the water soluble polymer is selected from cellulose derivates including carboxymethyl cellulose sodium and starch (claims 2-3). The products are applied onto a wound site and function as a hemostatic material (see Abstract). The water-soluble or “substrate polymer” provides an excellent protein supporting characteristic compared to composites in which protein is present on the surface of a composition (column 4, lines 21-33); the substrate polymer may improve dissolution of the hemostatic protein and flexibility of the sheet (column 5, lines 15-24).
Kageyama teaches that a formed sheet comprising fibrinogen preferably has a fibrinogen content in the range of 0.05 to 30 mg/cm2, and a film comprising fibrinogen preferably has a fibrinogen content in the range of 0.05 to 10 mg/cm2, in order to achieve a hemostatic effect while preventing the product from becoming fragile (column 7, lines 28-40 and column 13, lines 60-67), overlapping the ranges of instant claims 8 and 19. Kageyama further suggests that in a formed sheet product, the protein mass is in an amount of 50 to 100 mass% based on the substrate polymer in order to achieve adequate hemostatic and self-support properties; in a formed film products, the protein mass is in an amount of 100 mass% or more based on the substrate polymer in order to achieve adequate hemostatic properties and formability of a film (column 5, lines 33-51). Kageyama therefore suggests a polymer mass that is about 100% of the fibrinogen mass, or 0.05 to 30 mg/cm2 for a sheet and 0.05 to 10 mg/cm2 for a film, overlapping the ranges of instant claims 8 and 19.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the fibrinogen layer of the hemostatic films of Ericson with the carboxymethyl cellulose suggested by Kageyama. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to incorporate a polymer known to have excellent protein supporting characteristics in fibrinogen layers of hemostatic films and sheets, and to achieve a hemostatic sheet with improved dissolution and flexibility, as suggested by Kageyama (column 4, lines 21-33; column 5, lines 15-24). There is a reasonable expectation of success as the films of Ericson are taught to be flexible and comprise a fibrinogen-containing layer for use as a hemostat.
It would further have been prima facie obvious to routinely optimize the amounts of fibrinogen and carboxymethyl cellulose within the ranges suggested by Kageyama, overlapping the claimed ranges. One of ordinary skill would be motivated to routinely optimize these components to achieve a product that has both sufficient hemostatic properties and sufficient formability and support, as suggested by Kageyama. Per MPEP 2144.05 II. A., "[W]here 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” and per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Ericson does not teach that a linker covalently connect fibrinogen to the structural layer (instant claim 1), that the linker is an NHS-ester-derived non-reactive linker (instant claim 5), or that the linker is a bis-N-succinimidyl diglycolic acid-derived linker (instant claim 6).
Bordoloi teaches a tissue adhesive or sealant composition comprising an electrophilic group containing cross-linking compound having a linker moiety of a diglycolic acid and an electrophilic group covalently bonded to the linker and a nucleophilic group containing protein (see entire document, particularly abstract), particularly fibrinogen (paragraph [0023]). The cross-linking agent reacts with nucleophilic groups on plasma-derived protein to form a proteinaceous network, such as a fibrinogen matrix (paragraph [0029]). The cross-linker system is preferably a diglycolic acid active ester wherein an NHS end group has reacted via its N-Hydroxyl functionality with the di-acid (a bis-N-succinimidyl diglycolic acid-derived linker); the reaction binds NHS end group with the carboxylic functionality of the di-acid (paragraphs [0040]). The sealant system can be used on an absorbable or non-absorbable matrix, backing, or supporting scaffold for forming a patch (paragraph [0045]), and sealants are suitable for wound healing (paragraph [0043]). The cross-linker derivatives were found to provide rapid cure with plasma-derived proteins and a relatively extended absorption period as a sealant and/or adhesive (paragraph [0040]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the hemostatic films of Ericson to covalently cross-link the fibrinogen-containing layer to the plasma film (which comprises plasma-containing proteins) using the NHS-diglycolic acid-derived linker suggested by Bordoloi. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to achieve a fibrinogen matrix with an extended absorption period which can be used as a sealant in wound healing, as suggested by Bordoloi (particularly paragraphs [0002], [0040], and [0042]).There is a reasonable expectation of success as the films of Ericson are taught to comprise plasma and a fibrinogen-containing layer, and are used in wound-healing and sealing applications (pg. 1, lines 11-18; pg. 11, lines 4-11).
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 1-10 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 11-13, 18, and 21 of U.S. Patent No. 11,383,001 B2 in view of Ericson (WO 2017/210267 A2, published December 7th, 2017; included on IDS submitted 08/09/2024), Kageyama et al. (US 10,485,894 B2, patented November 26th, 2019), hereafter “Kageyama”, and Bordoloi et al. (US 2012/0288530 A1, published November 15, 2012), hereafter “Bordoloi”.
Claims 1-10 and 18-19 are directed to an invention not patentably distinct from claims 1, 8-9, 11-13, 18, and 21 of commonly assigned U.S. Patent No. 11,383,001 B2.
The claims of U.S. Patent No. US 11,383,001 B2 are drawn to a method of making a flexible plasma-based film. Similar to the medical device of the instant claims, the plasma-based film made by the method of U.S. Patent No. 11,383,001 B2 comprises a plasma-based film (sheet-like) structural layer with a layer of fibrinogen topically applied onto one side of the film (proximal to the structural layer), a separation layer comprising starch subsequently applied, and thrombin topically applied to the separation layer (distal to the structural layer). The films made by the method U.S. Patent No. 11,383,001 B2 comprise an amount of thrombin, a thickness, and a burst pressure consistent with the ranges instantly claimed.
Per the instant specification, “the term “water-activatable adhesive component” means a multilayered component of the device of the present invention that mediates affixation of the medical device of the present invention to the site of injury, trauma or surgery, where the device is to be used as a hemostat. The layer most distant to the structural layer of the device is a thrombin layer. It is the thrombin layer that mediates the adhesive properties of the adhesive component when rehydrated by an aqueous solution such as blood…” (pg. 9, line 33-pg. 10, line 10). As noted above, the multilayered component of the claims of U.S. Patent No. US 11,383,001 B2 comprises a distal thrombin layer, and is interpreted to be consistent with the provided definition of “water-activatable adhesive component”. It is further interpreted that the distal thrombin of the multilayered component mediates fixation when placed at the site of a wound.
The claims of US Patent No. 11,383,001 B2 do not recite that the device is biodegradable and non-porous, that the thrombin layer comprises between about 15 and about 30 IU of thrombin per cm2, or that the opposing side of the structural layer provides the device with an adhesion barrier function.
Ericson teaches flexible plasma-based films useful as a hemostat (see entire document, particularly abstract) which may comprise several layers (claim 21). The films of Ericson are taught to be fully biodegradable (pg. 26, lines 17-19). Ericson teaches that fibrinogen is topically applied onto the film (proximal to the structural layer), a separation layer comprising starch is applied, and thrombin is topically applied to the separation layer (distal to the structural layer) (claims 23-24). The fibrinogen, starch, and thrombin are taught to be applied to one side of the plasma-based films (see Example 1 at pg. 34-35 and Figure 3). Per the instant specification, “the term “non-porous”, in general refers to structures or devices that have such a low degree of porosity such that they do not allow for transmission of liquids such as water or blood through the structure or device itself. Therefore, such structures or devices can act at sealants to stem the immediate flow of such liquids…” (pg. 9, lines 3-11). The films of Ericson are taught to seal bleeds (pg. 11, lines 4-11) and are effective to stop bleeding (see Example 1 at pg. 34-35), and are thus interpreted as consistent with the provided definition of “non-porous”.
Ericson teaches applying about 5 ml of a 300 IU/ml thrombin solution on a 4”x4” film (pg. 15, lines 9-18). Thus, Ericson teaches applying about 1500 IU (5 ml x 300IU/ml) of thrombin per approximately 103.2 cm2 (1 in = 2.54 cm, 4 in = 10.16 cm, 16 in2 = 103.2 cm2), or about 14.5 IU per cm2, consistent with the range of “between about 15 and about 30” of the instant claims. Ericson teaches that the plasma-based films (side opposing the distal thrombin layer) can act as an anti-adhesive sheet to reduce or prevent development of surgery-induced adhesions (abstract; pg. 12, lines 1-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the multilayered film made by the method of US Patent No. 11,383,001 B2 to be biodegradable and non-porous with adhesion barrier function and an amount of thrombin consistent with the instant claims, as suggested by Ericson. One of ordinary skill in the art would have been motivated to do so to achieve a film that can stop mild to severe bleeding and prevent the development of surgery-induced adhesion and post-surgical complications and which degrades to suit the particular function, such as promoting healing (pg. 11, lines 4-22; pg. 16, lines 27-34).
The claims of US Patent No. 11,383,001 B2 do not teach the inclusion of carboxymethyl cellulose, as recited by the instant claims, nor the amounts of fibrinogen and CMC per cm2 recited by the instant claims.
Kageyama teaches a formed sheet product comprising a polymer composition layer comprising fibrinogen and a water-soluble polymer and a second polymer layer comprising thrombin (see entire document, particularly Abstract and claim 1); the water soluble polymer is selected from cellulose derivates including carboxymethyl cellulose sodium and starch (claims 2-3). The products are applied onto a wound site and function as a hemostatic material (see Abstract). The water-soluble or “substrate polymer” provides an excellent protein supporting characteristic compared to composites in which protein is present on the surface of a composition (column 4, lines 21-33); the substrate polymer may improve dissolution of the hemostatic protein and flexibility of the sheet (column 5, lines 15-24).
Kageyama teaches that a formed sheet comprising fibrinogen preferably has a fibrinogen content in the range of 0.05 to 30 mg/cm2, and a film comprising fibrinogen preferably has a fibrinogen content in the range of 0.05 to 10 mg/cm2, in order to achieve a hemostatic effect while preventing the product from becoming fragile (column 7, lines 28-40 and column 13, lines 60-67), overlapping the ranges of instant claims 8 and 19. Kageyama further suggests that in a formed sheet product, the protein mass is in an amount of 50 to 100 mass% based on the substrate polymer in order to achieve adequate hemostatic and self-support properties; in a formed film products, the protein mass is in an amount of 100 mass% or more based on the substrate polymer in order to achieve adequate hemostatic properties and formability of a film (column 5, lines 33-51). Kageyama therefore suggests a polymer mass that is about 100% of the fibrinogen mass, or 0.05 to 30 mg/cm2 for a sheet and 0.05 to 10 mg/cm2 for a film, overlapping the ranges of instant claims 8 and 19.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the fibrinogen layer of the films of US Patent No. 11,383,001 B2 with the carboxymethyl cellulose suggested by Kageyama. One of ordinary skill in the art would have been motivated to incorporate a polymer known to have excellent protein supporting characteristics in fibrinogen layers of hemostatic films and sheets, and to achieve a hemostatic sheet with improved dissolution and flexibility, as suggested by Kageyama (column 4, lines 21-33; column 5, lines 15-24). It would further have been prima facie obvious to routinely optimize the amounts of fibrinogen and carboxymethyl cellulose within the ranges suggested by Kageyama, overlapping the claimed ranges. One of ordinary skill would be motivated to routinely optimize these components to achieve a product that has both sufficient hemostatic properties and sufficient formability and support, as suggested by Kageyama. Per MPEP 2144.05 II. A., "[W]here 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” and per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”
The claims of US Patent No. 11,383,001 B2 do not teach that a linker covalently connect fibrinogen to the structural layer, that the linker is an NHS-ester-derived non-reactive linker, or that the linker is a bis-N-succinimidyl diglycolic acid-derived linker.
Bordoloi teaches a tissue adhesive or sealant composition comprising an electrophilic group containing cross-linking compound having a linker moiety of a diglycolic acid and an electrophilic group covalently bonded to the linker and a nucleophilic group containing protein (see entire document, particularly abstract), particularly fibrinogen (paragraph [0023]). The cross-linking agent reacts with nucleophilic groups on plasma-derived protein to form a proteinaceous network, such as a fibrinogen matrix (paragraph [0029]). The cross-linker system is preferably a diglycolic acid active ester wherein an NHS end group has reacted via its N-Hydroxyl functionality with the di-acid (a bis-N-succinimidyl diglycolic acid-derived linker); the reaction binds NHS end group with the carboxylic functionality of the di-acid (paragraphs [0040]). The sealant system can be used on an absorbable or non-absorbable matrix, backing, or supporting scaffold for forming a patch (paragraph [0045]), and sealants are suitable for wound healing (paragraph [0043]). The cross-linker derivatives were found to provide rapid cure with plasma-derived proteins and a relatively extended absorption period as a sealant and/or adhesive (paragraph [0040]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the film of the claims of US Patent No. 11,383,001 B2 to covalently cross-link the fibrinogen-containing layer to the plasma film (which comprises plasma-containing proteins) using the NHS-diglycolic acid-derived linker suggested by Bordoloi. One of ordinary skill in the art would have been motivated to do so in order to achieve a fibrinogen matrix with an extended absorption period which can be used as a sealant in wound healing, as suggested by Bordoloi (particularly paragraphs [0002], [0040], and [0042]).
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly
assigned US Patent No. 11,383,001 B2, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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