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 .
This action is responsive to papers filed 01/08/2026.
Claims 1-2, 11-12, 14, 20, 27, and 29 have been amended.
Claims 9, 13, and 28 have been newly canceled and no claims have been newly added.
Claims 1-3, 11-12, 14, 20, 22, 27, and 29 are currently pending and have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 11-12, 14, 20, 22, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over O’Heeron et al (CN-111630154A- using machine translation) as evidenced by Alt et al (Biology of the Cell, 2011) and Mitsialis et al (US 2017/0258840-from IDS filed 09/23/2022) and further in view of Nishino et al (WO 2014/017513) and Cho et al (British Journal of Dermatology, 2019).
The applied reference has a common joint 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).
Regarding claims 1-2, 11-12, O’Heeron teach methods and compositions using prepared fibroblasts and/or conditioned media from them (fibroblast-derived product) (abstract, page 4 of machine translation). These compositions are used to treat inflammatory diseases including asthma (page 18 of machine translation).
Regarding claim 3, O’Heeron is silent with regard to the property of plastic adherence, and expression of CD105 and CD73, however these are inherent properties of fibroblasts as evidenced by Alt (abstract, page 204) and Mitsialis (exosomes isolated from fibroblast conditioned medium include CD105 positive expression, abstract).
Regarding claims 29, O’Heeron is silent with regard to the property of wherein the conditioned media stimulates proliferation of CD8+ cells in the subject or wherein the fibroblasts and/or fibroblast-derived products inhibit eosinophil activation, basophil activation and/or mast cell activation in the subject, however these are deemed to be inherent properties of the method of administering conditioned media of fibroblasts and/or fibroblasts to a patient with asthma.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Regarding claim 14, O’Heeron teach that their fibroblasts are characterized by cell factor secretion such as FGF-1 and FGF-2 (page 5 of machine translation) and thus the conditioned media will contain these growth factors secreted by the fibroblasts.
Regarding claims 20 and 22, O’Heeron is silent with regard to the property of wherein the conditioned media contains exosomes that comprise CD81, however this is deemed to be an inherent property of the conditioned media obtained from fibroblasts as evidence by Mitsialis (exosomes isolated from fibroblast conditioned medium include CD81 positive expression, page 1 para 5).
Regarding claims 27, O’Heeron teach wherein the conditioned medium may have anti-inflammatory activity and thus can be used as an anti-inflammatory agent due to an exposure to an allergic response and other forms of inflammation known to those skilled in art (page 8 of the machine translation). Asthma attacks are well known in the art to occur due to an allergic response (exposure to an allergen) and thus an obvious option for application of the method.
The specific combination of features claimed is disclosed within the broad genera of inflammatory diseases and fibroblast composition types taught by O’Herron, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of inflammatory diseases (asthma) and fibroblast composition types (fibroblast or fibroblast conditioned medium) from within the disclosure of O’Heeron to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that O’Heeron suggests that all these cited variables are suitable for inclusion in their method/composition.
O’Heeron render obvious the claimed invention as described above, but do not specifically teach exposing the fibroblasts to oxytocin prior to providing the subject with the fibroblast product.
Nishino disclose a culture medium composition for culturing cells (abstract) including wherein the cells are fibroblasts (page 6 of machine translation). Nishino disclose wherein hormones are added to the medium and include oxytocin as a suitable hormone to be added (page 18 of the machine translation).
Cho teach that oxytocin is a hormone that has many beneficial biological effects including the alleviation of cell senescence (cell deterioration with age) of fibroblasts in culture (page 1216, summary, page 1218 results).
One of ordinary skill in the art would have been motivated to use the oxytocin containing culture medium of Nishino to culture the fibroblasts of O’Heeron because Nishino indicate that their culture medium is suitable for the culture of fibroblasts and Cho teach that oxytocin is a hormone that has many beneficial biological effects including the alleviation of cell senescence (cell deterioration with age) of fibroblasts in culture (page 1216, summary, page 1218 results). One of ordinary skill in the art would have been motivated to use an amount of oxytocin that produced a beneficial effect on the fibroblasts as suggested by Cho and thus provide an effective amount. One of ordinary skill in the art would have had a reasonable expectation of success because O’Heeron teach that any type of culture medium known to one of ordinary skill in the art can be used with their fibroblast cultures (page 16 of machine translation).
Therefore, the combined teachings of O’Heeron et al, Nishino et al and Cho et al render obvious Applicant’s invention as claimed.
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.
Claim(s) 1-3, 11-12, 14, 20, 22, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Lafont et al (WO 2018/091698) as evidenced by Alt et al (Biology of the Cell, 2011) and Mitsialis et al (US 2017/0258840-from IDS filed 09/23/2022) and further in view of Nishino et al (WO 2014/017513) and Cho et al (British Journal of Dermatology, 2019).
Regarding claims 1-3, 11-12, 14, 20 and 22, Lafont teach compositions comprising a gingival fibroblast-derived product useful for the treatment of immune-related diseases (abstract), such as asthma (page 15 claim 3) and wherein the product included fibroblast whole cells, a fibroblast culture, a fibroblast extract or fibroblast conditioned medium (page 15 claim 5). Lafont teach wherein “gingival fibroblast-derived product” relates to any product which can be obtained from gingival fibroblasts in themselves or which contains gingival fibroblast secretions (page 5) and thus inherently contain FGF-1, FGF-2 and exosomes that comprise CD81. Fibroblasts are inherently adherent to plastic.
Regarding claims 29, Lafont is silent with regard to the property of wherein the conditioned media stimulates proliferation of CD8+ cells in the subject or wherein the fibroblasts and/or fibroblast-derived products inhibit eosinophil activation, basophil activation and/or mast cell activation in the subject, however these are deemed to be inherent properties of the method of administering conditioned media of fibroblasts and/or fibroblasts to a patient with asthma.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Regarding claims 27, Lafont teach wherein the fibroblast-derived product (fibroblast-derived conditioned medium) has an anti-inflammatory activity and thus can be used as an anti-inflammatory agent due to an exposure to an allergic response and other forms of inflammation known to those skilled in art (pages 12-13, page 15 claims 1-7). Asthma attacks are well known in the art to occur due to an allergic response (exposure to an allergen) and thus an obvious option for application of the method.
The specific combination of features claimed is disclosed within the broad genera of inflammatory diseases and fibroblast composition types taught by Lafont, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of immune-related inflammatory diseases (asthma) and fibroblast composition types (fibroblast or fibroblast conditioned medium) from within the disclosure of Lafont to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that Lafont suggests that all these cited variables are suitable for inclusion in their method/composition.
Lafont render obvious the claimed invention as described above, but do not specifically teach exposing the fibroblasts to oxytocin prior to providing the subject with the fibroblast product.
Nishino disclose a culture medium composition for culturing cells (abstract) including wherein the cells are fibroblasts (page 6 of machine translation). Nishino disclose wherein hormones are added to the medium and include oxytocin as a suitable hormone to be added (page 18 of the machine translation).
Cho teach that oxytocin is a hormone that has many beneficial biological effects including the alleviation of cell senescence (cell deterioration with age) of fibroblasts in culture (page 1216, summary, page 1218 results).
One of ordinary skill in the art would have been motivated to use the oxytocin containing culture medium of Nishino to culture the fibroblasts of Lafont because Nishino indicate that their culture medium is suitable for the culture of fibroblasts and Cho teach that oxytocin is a hormone that has many beneficial biological effects including the alleviation of cell senescence (cell deterioration with age) of fibroblasts in culture (page 1216, summary, page 1218 results). One of ordinary skill in the art would have been motivated to use an amount of oxytocin that produced a beneficial effect on the fibroblasts as suggested by Cho and thus provide an effective amount. One of ordinary skill in the art would have had a reasonable expectation of success because Lafont teach that any type of culture medium known to one of ordinary skill in the art to sustain survival and/or growth of gingival fibroblasts can be used with their fibroblast cultures (page 6).
Therefore, the combined teachings of Lafont et al, Nishino et al and Cho et al render obvious Applicant’s invention as claimed.
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 1-3, 9, 11-14, 20, 22, and 27-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-12, 14-16, 22-25, 29, 31-35, 39-42, 44-46, 53-55, and 59-60 of copending Application No. 17/757383 in view of Lafont et al (WO 2018/091698), Alt et al (Biology of the Cell, 2011), Mitsialis et al (US 2017/0258840-from IDS filed 09/23/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application are drawn to a method of treating a lung disease, such as asthma, by administering an effective amount of fibroblasts and/or functional derivative, such as exosomes, to a subject and wherein the fibroblasts express CD73 and include exposing the fibroblasts to oxytocin.
Although the patent does not claim fibroblast-derived products such as conditioned medium or the effects of the fibroblasts on the subject these are deemed to be obvious additions in view of Lafont, Alt, and Mitsialis.
Lafont teach compositions comprising a gingival fibroblast-derived product useful for the treatment of immune-related diseases (abstract), such as asthma (page 15 claim 3) and wherein the product included fibroblast whole cells, a fibroblast culture, a fibroblast extract or fibroblast conditioned medium (page 15 claim 5). Lafont teach wherein “gingival fibroblast-derived product” relates to any product which can be obtained from gingival fibroblasts in themselves or which contains gingival fibroblast secretions (page 5) and thus inherently contain FGF-1, FGF-2 and exosomes that comprise CD81. Fibroblasts are inherently adherent to plastic.
Regarding claim 3, with regard to the property of plastic adherence, and expression of CD105 and CD73, these are inherent properties of fibroblasts as disclosed by Alt (abstract, page 204) and Mitsialis (exosomes isolated from fibroblast conditioned medium include CD105 positive expression, abstract).
Regarding claims 13 and 29, with regard to the property of wherein the conditioned media stimulates proliferation of CD8+ cells in the subject or wherein the fibroblasts and/or fibroblast-derived products inhibit eosinophil activation, basophil activation and/or mast cell activation in the subject, however these are deemed to be inherent properties of the method of administering conditioned media of fibroblasts and/or fibroblasts to a patient with asthma.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Regarding claims 27-28, Lafont teach wherein the fibroblast-derived product ( fibroblast-derived conditioned medium) has an anti-inflammatory activity and thus can be used as an anti-inflammatory agent due to an exposure to an allergic response and other forms of inflammation known to those skilled in art (pages 12-13, page 15 claims 1-7). Asthma attacks are well known in the art to occur due to an allergic response (exposure to an allergen) and thus an obvious option for application of the method.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to include the conditioned medium of fibroblasts in the method of the copending claims because LaFont, Alt and Mitsialis teach and suggest that this fibroblast-derived product is beneficial and suitable as an alternative or in addition to fibroblasts for the treatment of asthma.
Therefore, the combined teachings of the copending claims, Lafont et al, Alt et al and Mitsialis et al render obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 11-12, 14, 20, 22, 27, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,975,030 in view of Lafont et al (WO 2018/091698), Alt et al (Biology of the Cell, 2011), Mitsialis et al (US 2017/0258840-from IDS filed 09/23/2022) Nishino et al (WO 2014/017513) and Cho et al (British Journal of Dermatology, 2019).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of treating a lung disease, such as asthma, by administering an effective amount of fibroblasts to a subject wherein the fibroblasts express CD73.
Although the patent does not claim fibroblast-derived products such as conditioned medium, exosomes, the exposure to oxytocin, or the effects of the fibroblasts on the subject these are deemed to be obvious additions in view of Lafont, Alt, Mitsialis, Nishino and Cho.
Lafont teach compositions comprising a gingival fibroblast-derived product useful for the treatment of immune-related diseases (abstract), such as asthma (page 15 claim 3) and wherein the product included fibroblast whole cells, a fibroblast culture, a fibroblast extract or fibroblast conditioned medium (page 15 claim 5). Lafont teach wherein “gingival fibroblast-derived product” relates to any product which can be obtained from gingival fibroblasts in themselves or which contains gingival fibroblast secretions (page 5) and thus inherently contain FGF-1, FGF-2 and exosomes that comprise CD81. Fibroblasts are inherently adherent to plastic.
Regarding claim 3, with regard to the property of plastic adherence, and expression of CD105 and CD73, these are inherent properties of fibroblasts as disclosed by Alt (abstract, page 204) and Mitsialis (exosomes isolated from fibroblast conditioned medium include CD105 positive expression, abstract).
Regarding claims 29, with regard to the property of wherein the conditioned media stimulates proliferation of CD8+ cells in the subject or wherein the fibroblasts and/or fibroblast-derived products inhibit eosinophil activation, basophil activation and/or mast cell activation in the subject, however these are deemed to be inherent properties of the method of administering conditioned media of fibroblasts and/or fibroblasts to a patient with asthma.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Regarding claims 27, Lafont teach wherein the fibroblast-derived product ( fibroblast-derived conditioned medium) has an anti-inflammatory activity and thus can be used as an anti-inflammatory agent due to an exposure to an allergic response and other forms of inflammation known to those skilled in art (pages 12-13, page 15 claims 1-7). Asthma attacks are well known in the art to occur due to an allergic response (exposure to an allergen) and thus an obvious option for application of the method.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to include the conditioned medium of fibroblasts in the method of the copending claims because LaFont, Alt and Mitsialis teach and suggest that this fibroblast-derived product is beneficial and suitable as an alternative or in addition to fibroblasts for the treatment of asthma.
Nishino disclose a culture medium composition for culturing cells (abstract) including wherein the cells are fibroblasts (page 6 of machine translation). Nishino disclose wherein hormones are added to the medium and include oxytocin as a suitable hormone to be added (page 18 of the machine translation).
Cho teach that oxytocin is a hormone that has many beneficial biological effects including the alleviation of cell senescence (cell deterioration with age) of fibroblasts in culture (page 1216, summary, page 1218 results).
One of ordinary skill in the art would have been motivated to use the oxytocin containing culture medium of Nishino to culture the fibroblasts of the patent because Nishino indicate that their culture medium is suitable for the culture of fibroblasts and Cho teach that oxytocin is a hormone that has many beneficial biological effects including the alleviation of cell senescence (cell deterioration with age) of fibroblasts in culture (page 1216, summary, page 1218 results). One of ordinary skill in the art would have been motivated to use an amount of oxytocin that produced a beneficial effect on the fibroblasts as suggested by Cho and thus provide an effective amount. One of ordinary skill in the art would have had a reasonable expectation of success because Lafont teach that any type of culture medium known to one of ordinary skill in the art to sustain survival and/or growth of gingival fibroblasts can be used with fibroblast cultures (page 6).
Therefore, the combined teachings of the patent claim, Lafont et al, Alt et al, Mitsialis et al, Nishino et al and Cho et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not fully persuasive. Applicant’s amendments have overcome the previous obviousness rejections that do not include the Nishino and Cho references, however these rejections have been replaced with new obviousness rejections that rely on the combination of O’Heeron, Nishino and Cho as described above.
Applicant argues that none of the claims in the U.S. Patent 11,975,030 make reference to using oxytocin to pretreat fibroblasts and neither do the secondary references and as such the double patenting rejection relying on this patent should be withdrawn.
This is not found persuasive. The double patenting rejection over U.S. Patent 11,975,030 also relies on the teachings of Nishino et al and Cho et al which teach and suggest the use of oxytocin to pretreat fibroblasts as described above.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sorg et al., "Oxytocin effects on experimental skin wound healing", Innovative Surgical Sciences, 2017, Vol. 2, Issue 4, pp. 219-232.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631