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 .
Claims Status
Claims 5,7-8,24,25-27, and 29 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-4, 6, 9, 21-23, 28, and 30-31 are under current examination.
Applicants note that claims 5 and 7 and 24-27 and 29 part of invention of Group 1 so should be examined also.
Examiner respectfully submits that claims 5 and 7 are directed to active agents that are not part of the elected species to latanoprost (response to species election filed on 08/29/2025). The elected species are glutaric anhydride and latanoprost as the further active. Examiner notes that should generic claim 1 be found allowable that the withdrawn species will be reconsidered for potential rejoinder.
Applicants' arguments amendments filed on 03/03/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 1-4, 6, 9, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over DeVore et al. (United States Patent Publication 20130129807) in view of Spiro et al. (United States Patent Publication 20040224027) and Ying et al. (In Situ Formed Collagen-Hyaluronic Acid Hydrogel as Biomimetic Dressing for Promoting Spontaneous Wound Healing).
The instant claims are being examined to the extent of the elected species in that the derivatized collagen that is crosslinked with hyaluronic acid is derivatized with glutaric anhydride and the active agent is latanoprost.
DeVore et al. teach collagen derivatized with an acylating agent alters the ionic charge and density of the collagen composition, see abstract and paragraph [0031]. Examples of the acylation agent include glutaric anhydride, see paragraph [0031], and Examples 1-2. The collagen based film or membrane can be used anywhere in the body that prolongs delivery of a precise dose of drug or agent needed, see paragraph [0029]. Collagen constructs can provide the sustained release of latanoprost ( a prostaglandin analog, aka 13,14-dihydro-17-phenyl-18,19,20-trinor-prostaglandin F2a-1-isopropyl ester), see paragraph [0107]. Such drugs are effective when glaucoma treatment is desired, see paragraph [0120] and [0132] and [0162] . The film or membrane contains extended therapeutic concentrations of drugs that are exposed to ultraviolet irradiation in a nitrogen atmosphere from about 2 to 20 minutes, see paragraphs [0033]-[0035]. The latanoprost is present from at least about 150 micrograms per film per at least 90 days, and in another embedment at least 300 micrograms per film or membrane per at leat 180 days, see paragraph [0035]. The zero order release can be greater than one month, greater than two months or greater than three months, see paragraphs [0081] and [0107]. The collagen based film or membrane comprises at least one layer, see claims 1-5. The film or membrane delivery system can be multi-layered rendering obvious at least two layers, see paragraph [0030] and [0077]. At least of the layers of the film or membrane delivery system can comprise a rate controlling layer, see paragraph [0030].
DeVore et al. does not expressly teach that the collagen based film or membrane contains hyaluronic acid chemically crosslinked to collagen.
Spiro et al. teach that collagen and hyaluronic acid matrices (COL/HA) are useful for drug delivery, see abstract. The hyaluronic acid (HA) and collagen protein are cross linked, see paragraphs [0007], [0020], [0022], examples 1-6 and claims 1-2 and 4.
Ying et al. teach that it is found that hyaluronic acid (HA) takes an important role in the process of angiogenesis, which is quite essential for wound healing but must be compounded with other molecules for sufficient mechanical strength, see introduction. COL-HA (collagen-hyaluronic acid) exhibited the best wound repair ability resulting in improved biocompatibility and enhancing cell growth, see section 3.9. Collagen promotes clotting and cell adhesion while the hyaluronic acid maintains a moist environment as well as increased absorption of wound exudate, see introduction and section 3.9. These properties are beneficial to stimulate angiogenesis and epithelium, see section 3.9. Together, HA-COL is biocompatible and provides biodegradation properties, see abstract, introduction, and section 3.5 and conclusion.
It would have been prima facie obvious to provide the drug delivery collagen film or membrane of DeVore et al. with crosslinked hyaluronic acid.
One of ordinary skill in the art would have been motivated to form a collagen-hyaluronic acid crosslinked film because Spiro teaches that collagen and hyaluronic acid films can be used for drug delivery, and hyaluronic acid per the teachings of Ying provides essential wound healing properties while together a COL-HA based polymer is biocompatible and provides biodegradation properties. There would have been a reasonable expectation of success because DeVore et al. utilizes collagen based films for a sustained release of drugs.
Claims 1-4, 6, 9, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 103 as being obvious over DeVore et al. (United States Patent Publication 20130129807) in view of Devore et al. -hereafter DeVore2 et al. (United States Patent 12304974).
The instant claims are being examined to the extent of the elected species in that the derivatized collagen that is crosslinked with hyaluronic acid is derivatized with glutaric anhydride and the active agent is latanoprost.
The applied DeVore2 reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
DeVore et al. teach collagen derivatized with an acylating agent alters the ionic charge and density of the collagen composition, see abstract and paragraph [0031]. Examples of the acylation agent include glutaric anhydride, see paragraph [0031], and Examples 1-2. The collagen based film or membrane can be used anywhere in the body that prolongs delivery of a precise dose of drug or agent needed, see paragraph [0029]. Collagen constructs can provide the sustained release of latanoprost ( a prostaglandin analog- aka 13,14-dihydro-17-phenyl-18,19,20-trinor-prostaglandin F2a-1-isopropyl ester), see paragraph [0107]. Such drugs are effective when glaucoma treatment is desired, see paragraph [0120] and [0132] and [0162]. The film or membrane contains extended therapeutic concentrations of drugs that are exposed to ultraviolet irradiation in a nitrogen atmosphere from about 2 to 20 minutes, see paragraphs [0033]-[0035]. The latanoprost is present from at least about 150 micrograms per film per at least 90 days, and in another embedment at least 300 micrograms per film or membrane per at least 180 days, see paragraph [0035]. The zero order release can be greater than one month, greater than two months or greater than three months, see paragraphs [0081] and [0107]. The collagen based film or membrane comprises at least one layer, see claims 1-5. The film or membrane delivery system can be multi-layered rendering obvious at least two layers, see paragraph [0030] and [0077]. At least of the layers of the film or membrane delivery system can comprise a rate controlling layer, see paragraph [0030].
DeVore et al. does not expressly teach that their collagen based film or membrane comprises crosslinked hyaluronic acid.
Devore2 et al. teach crosslinked hyaluronic acid-collagen is useful for tissue augmentation, see column 4, lines 20-28. Hyaluronic acid (HA) exhibits unique viscous flow, elastic and pseudoplastic properties, see column 1, line 67-column 2 lines 1-2. HA has been demonstrated to be important in different activities such as tissue hydration, lubrication, solute transportation, cell migration, cell function, cell differentiation, and cell proliferation, see column 2, lines 4-7.The polymer has enhanced stability with improved longevity of the copolymer in vivo, see column 4, lines 46-48. DeVore et al. discloses glycosaminoglycan-collagen which contains hyaluronic acid as the glycosaminoglycan, see claim 1. The collagen is derivatized with glutaric anhydride, see claims 1 and 5. The composition delivers drugs to tissue, see column 4, lines 1-6.
It would have therefore been prima facie obvious to modify the collagen based film or membrane of DeVore et al. to include crosslinked hyaluronic acid as taught by DeVore2 et al.
One of ordinary skill in the art would have been motivated to do so because collagen with crosslinked hyaluronic acid improves longevity of the polymer and provides for enhanced stability. There would have been a reasonable expectation of success because DeVore et al. utilizes collagen based films for a sustained release of drugs.
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 1-4, 6, 9, 21-23, 28 and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 16 of U.S. Patent No. 9289396 in view of Spiro et al. (United States Patent Publication 20040224027) and Ying et al. (In Situ Formed Collagen-Hyaluronic Acid Hydrogel as Biomimetic Dressing for Promoting Spontaneous Wound Healing).
Claims 1-4, 6, 9, 21-23, 28 and 30-31 directed to an invention not patentably distinct from claims 1-9 and 16 of U.S. Patent 9289396.
Both the instant claims and that of Patent ‘396 require a collagen based layer that is crosslinked and derivatized with an acylation agent including glutaric anhydride to alter ionic charge and makes up a film or membrane. The composition in both Patent ‘396 and the instant claims further comprises latanoprost for drug delivery. The claims of Patent ‘396 include at least about 300 micrograms of latanoprost for at least about 180 days meeting the recitation of instant claim 9 of at least 300 micrograms for about 6 months.
The difference between the instant claims and that of Patent ‘396 is that the collagen based film comprises crosslinked hyaluronic acid.
However, Spiro et al. teach that collagen and hyaluronic acid matrices (COL/HA) are useful for drug delivery, see abstract. The hyaluronic acid (HA) and collagen protein are cross linked, see paragraphs [0007], [0020], examples 1-6 and claims 1-2 and 4.
Ying et al. teach that it is found that hyaluronic acid (HA) takes an important role in the process of angiogenesis, which is quite essential for wound healing but must be compounded with other molecules for sufficient mechanical strength, see introduction. COL-HA (collagen-hyaluronic acid) exhibited the best wound repair ability resulting in improved biocompatibility and enhancing cell growth, see section 3.9. Collagen promotes clotting and cell adhesion while the hyaluronic acid maintains a moist environment as well as increased absorption of wound exudate, see introduction and section 3.9. These properties are beneficial to stimulate angiogenesis and epithelium, see section 3.9. Together, HA-COL is biocompatible and provides biodegradation properties, see abstract, introduction, and section 3.5 and conclusion.
It would have been obvious to provide the drug delivery collagen based film or membrane of Patent ‘396 with crosslinked hyaluronic acid.
One of ordinary skill in the art would have been motivated to form a collagen-hyaluronic acid film because Spiro teaches that collagen and hyaluronic acid films can be used for drug delivery and hyaluronic acid provides essential wound healing.
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 Patent 9289396, 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.
Claims 1-4, 6, 9, 21-23, 28 and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 16 of U.S. Patent No. 9289396 in view of Devore et al.-hereafter DeVore2 et al. (United States Patent 12304974).
Claims 1-4, 6, 9, 21-23, 28 and 30-31 directed to an invention not patentably distinct from claims 1-9 and 16 of U.S. Patent 9289396.
Both the instant claims and that of Patent ‘396 require a collagen based layer that is crosslinked and derivatized with an acylation agent including glutaric anhydride to alter ionic charge and makes up a film or membrane. The composition in both Patent ‘396 and the instant claims further comprises latanoprost for drug delivery. The claims of Patent ‘396 include at least about 300 micrograms of latanoprost for at least about 180 days meeting the recitation of instant claim 9 of at least 300 micrograms for about 6 months.
The difference between the instant claims and that of Patent ‘396 is that the collagen based film comprises crosslinked hyaluronic acid.
Devore2 et al. teach crosslinked hyaluronic acid-collagen is useful for tissue augmentation, see column 4, lines 20-28. Hyaluronic acid (HA) exhibits unique viscous flow, elastic and pseudoplastic properties, see column 1, line 67-column 2 lines 1-2. HA has been demonstrated to be important in different activities such as tissue hydration, lubrication, solute transportation, cell migration, cell function, cell differentiation, and cell proliferation, see column 2, lines 4-7.The polymer has enhanced stability with improved longevity of the copolymer in vivo, see column 4, lines 46-48. DeVore et al. discloses glycosaminoglycan-collagen which contains hyaluronic acid as the glycosaminoglycan, see claim 1. The collagen is derivatized with glutaric anhydride, see claims 1 and 5. The composition delivers drugs to tissue, see column 4, lines 1-6.
It would have been obvious to modify the collagen based film or membrane of Patent ‘396. to include crosslinked hyaluronic acid as taught by DeVore2 et al.
One of ordinary skill in the art would have been motivated to do so because collagen with crosslinked hyaluronic acid improves longevity of the polymer and provides for enhanced stability.
There would have been a reasonable expectation of success because Patent ‘396 utilizes collagen based films for a sustained release of drugs.
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 Patent 9289396, 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.
Response to remarks
Applicants argue that Spiro teaches at paragraph 0010 that the matrices comprise two porous polymeric layers that differ in their composition and that these polymer layers are separately prepared and assembled by chemically crosslinking or mechanical embedding. Spiro teaches that the COL (collagen) and the HA (hyaluronic acid) are separately crosslinked with DVS to form the crosslinked COL layer 10a and 10b at paragraph ]0024]. Applicants argue that Spiro examples are directed to bilayer systems wherein there is 100% COL in one layer and 100% HA in another layer thus teaching away from the instant invention which requires one discrete layer of both collagen and HA.
Examiner respectfully disagrees that Spiro teaches away from chemically crosslinking HA to COL. Paragraph [0022] of Spiro further supports that HA is chemically crosslinked to COL. Paragraph [0022] teaches that:
In one embodiment, the first polymeric layer is prepared by cross-linking a polysaccharide or protein to another polysaccharide or protein. The two polysaccharides or proteins may be the same or different from one another. For example, collagen may be cross-linked to collagen, or hyaluronate may be cross-linked to collagen. Various COL/HA ratios may be used. Typical ratios are 2:8 to 9:1 collagen to HA.
Thus, it is clear from the teachings of Spiro that alternative embodiments encompass crosslinking of HA directly to collagen. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005).
Applicants argue that the cited references fail to suggest the further requirement of claim 3 that the collagen is derivatized with acylating agent to alter the ionic charge and charge density. With regards to Ying Applicants argue that Ying operates by the mechanism of phenol grafting and coupling whereas the present claims utilize chemically derivatized collagen crosslinked with a hyaluronic acid wherein the collagen is derivatized with an acylating agent.
Applicants remarks are considered unpersuasive because DeVore et al. already teach collagen derivatized with an acylating agent alters the ionic charge and density of the collagen composition, see abstract and paragraph [0031]. Examples of the acylation agent include glutaric anhydride, see paragraph [0031], and Examples 1-2. Ying was cited to further support the advantages of HA and collagen. Together, HA-COL is biocompatible and provides biodegradation properties, see abstract, introduction, and section 3.5 and conclusion. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicants argue that zero order drug release or near zero order drug release of the present invention is desirable because the rate of drug release is independent of the initial concentration of the drug.
The examiner brings to applicant's attention that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Furthermore, zero order release is already suggested by the teachings of DeVore.
With regards to DeVore2 Applicants argue that this is non-analogous art and the proposed modification is improper. Applicants argue that the presently claimed invention is directed to a collagen-hyaluronic acid based film or membrane delivery system and that the inventors surprisingly discovered that the presently claimed film or membrane delivery system is uniquely positioned for sustained release of active agents or drugs. In contrast, DeVore2 is directed to a copolymer composition for augmenting soft tissue defects thus directed to a completely different field of endeavor.
The examiner brings to applicant's attention that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Here, it is not necessary that DeVore2 teach the same advantages as applicants. Furthermore, Examiner respectfully disagrees that Devore and Devore2 are not analogous because DeVore 2 like the DeVore reference delivers drugs to tissue, see column 4, lines 1-6. Thus the DeVore references are reasonably pertinent to the particular problem with which the inventor was concerned. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Examiner further notes that the instant claims are directed to a composition which can have any intended use.
With respect to the Double Patenting rejections Applicants note for the same reasons discussed above, the Double Patenting rejections should be withdrawn.
Examiner respectfully submits that for the same reasons discussed above with regards to DeVore, DeVore2 and Spiro, the Double Patenting rejections are maintained.
Conclusion
Applicant’s arguments/remarks are considered unpersuasive. 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).
Currently, no claims are allowed and all claims are rejected.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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