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 .
Status of Claims
Receipt of Remarks/Amendments filed on 06/23/2026 is acknowledged. Claims 1, 8, and 12-13 are amended and claims 2-3, 5-7, 9-11, and 14-20 are canceled. Claims 1, 4, 8, 12-13, and 21-23 are currently pending and are examined on the merits herein.
Priority
The instant application filed 08/05/2022, is a 371 filing of PCT/IB2021/05118, filed 02/12/2021, which claims foreign priority to IT 102020000002827, filed 02/13/2020.
Withdrawn Objections/Rejections
Claims 1, 11, 13, and 23 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sandri (WO 2019/021325 A1) as evidence by Sanford Chemicals. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1, 4-6, 11, 13, and 23 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peng (CN 110664619 A), as evidence by Sanford Chemicals. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1, 4-6, 11, 13, and 23 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peng2 (CN 109568173 B), as evidence by Sanford Chemicals. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1, 4-5, 11-13, and 23 were rejected under 35 U.S.C. 103 as being unpatentable over Sandri (WO 2019/021325 A1), as evidenced by Siddiq (2018). Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1, 6-8, 11, 13, and 23 were rejected under 35 U.S.C. 103 as being unpatentable over Sandri (WO 2019/021325 A1), in view of Xiao (CN 107675359 A). Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Claims 1, 4-8, and 11-13 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/844,848. Applicant’s amendments to claim 1 have overcome the rejection and the rejection is withdrawn.
Any additional rejections of claims 5-7 and 11 are withdrawn due to Applicant’s cancellation of these claims.
The following grounds of rejection are new and maintained, as necessitated by amendment:
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 8, and 13 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bonnet, I., et al. (US 20150209264 A1, 07/30/2015, PTO-892), hereinafter Bonnet.
Bonnet discloses a mixture of ingredients that makes it possible to reduce the insensible water losses and thus maintain the hydration of the skin ([0001]).
Regarding claims 1 and 8: The composition of Bonnet is a combination of pullulan or of a derivative thereof with a mixture of polysaccharides consisting of hyaluronic acid or a salt or derivative thereof and alginic acid or a salt or derivative thereof (abstract; claim 30). Example 3 teaches a composition having a combination according to the invention which is 0.25% by weight of pullulan, 0.25% by weight of hyaluronic acid, and 0.5% by weight of alginic acid in the form of sodium alginate ([0181]; Table 3 last entry). Such a composition was prepared as indicated in Example 1 which teaches mixing the components in deionized water ([0173]; [0149]). This composition therefore reads on consisting of hyaluronic acid, pullulan, water, and optionally a stabilizer, as recited in claim 1, wherein the stabilizer is an alginate, as recited in claim 8. While Bonnet does not teach hyaluronic acid to be a “first compound to be electrospun” nor pullulan to be an “electrospinning promoter”, these ingredients inherently possess the ability to act in these roles since their chemical identity is the same. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Furthermore, while Bonnet does not teach a composition “to be electrospun for forming a product that is absorbable by the skin”, such a recitation is simply a statement of intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). Furthermore, since the prior art teaches a composition which is structurally identical to that which is defined in the body of the claim it must inherently be capable of performing the recited function, whether or not the prior art explicitly defines such a use.
Regarding claim 4: The ratio between pullulan and hyaluronic acid in Example 3 is 1:1, which falls within the instantly claimed range (i.e., 4:1 to 1:7).
Regarding claim 13: Example 3 of Bonnett discloses various composition to be tested which are prepared as indicated in Example 1 via mixing the components at various concentrations in deionized water ([0149]; [0173]). The inventive composition comprises the components of pullulan and hyaluronic acid as discussed above ([0154]).
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.
1. Claims 1, 4, 8, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bonnet, I., et al. (US 20150209264 A1, 07/30/2015, PTO-892), hereinafter Bonnet.
The teachings of Bonnet are discussed above, as are the rejections of claims 1, 4, 8, and 13.
Bonnet further teaches wherein the weight ratio of pullulan/hyaluronic acid, is advantageously in the range 1/0.1-1/10 ([0033]). The three-part combination has a weight ratio of pullulan/ hyaluronic acid/alginic acid, salts or derivatives in the range of 1/1/1 to 1/10/10 (claim 38), which defines a pullulan/hyaluronic acid weight ratio of 1/1 to 1/10. Both weight ratio ranges encompass that of claim 12.
The teachings of Bonnet differ from that of the instantly claimed invention in that Bonnet does not explicitly teach an embodiment having the weight ratio of claim 12.
However, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to adjust the weight ratio of pullulan to hyaluronic acid in the composition of Bonnet to arrive at the instantly claimed range of 1:2 since Bonnet broadly teaches such a weight ratio as known and effective. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Vicini, S., et al., (2018), Alginate and alginate/hyaluronic acid membranes generated by electrospinning in wet conditions: Relationship between solution viscosity and spinnability. J. Appl. Polym. Sci., 46390 (on record) in view of Chen, G. et al. (2016). Preparation, characterization, and application of PEO/HA core shell nanofibers based on electric field induced phase separation during electrospinning, Polymer, Volume 83, Pages 12-19 (on record), hereinafter Chen, as evidence by Sanford Chemicals (2026). Can Hyaluronic Acid be Absorbed into the Skin, Hyaluronic Acid Supplier, (on record), hereinafter Sanford Chemicals.
Vicini teaches electrospinning in wet conditions to create alginate/hyaluronic acid membranes starting from blends of biopolymers with PEO (polyethylene oxide, i.e., poly(oxyethylene)) in water solutions (p. 2, paragraph 4).
Regarding claims 21 and 22: Vicini prepares several ternary systems by mixing the polymers sodium alginate, poly(ethylene oxide), and hyaluronic acid (SA/PEO/HA) (p. 2-3, Solutions Preparation; Table 1). The systems are then used in methods of electrospinning (p. 3, Membranes Preparation by Electrospinning), therefore reading on a composition to be electrospun as instantly claimed. The hyaluronic acid reads on the instantly claimed first compound to be electrospun while the alginate and PEO read on the electrospinning promotor. While these compounds are not explicitly defined as such by Vicini, "[p]roducts of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Vicini teaches ternary systems with ratios of SA/PEO/HMW-HA (high molecular weight HA) of 33:33:33, which comprise a 1:1 ratio of alginate and PEO as instantly claimed.
The entirety of Vicini explores optimizing viscosity and spinnability of electrospinning solutions by adjusting parameters such as HA molecular weight, total polymer concentration, and polymer weight ratio (Table 1; Title; Results and Discussion). Vicini teaches when using HMW-HA, the viscosity of the system was extremely high. Even when an electric field was applied at high voltage (i.e., 30 kV), it was impossible to overcome the surface tension and the elastic behavior of the solution, and therefore this system was discarded (p. 7, paragraph 1).
Vicini teaches that the biocompatible membranes generated from electrospinning had a tissue-like appearance. Therefore, they can be studied and their application will be experimented in tissue engineering, wound healing and release of drugs (p. 7, final paragraph).
The teachings of Vicini differ from that of the instant invention in that Vicini does not teach wherein the weight ratio of HA:promoter is 3:1 as defined in claims 21 and 22.
Chen teaches fabricating PEO/HA core-shell nanofibers via homogeneous electrospinning (abstract; p. 13, para. 3, Intro). Poly(ethylene oxide) (PEO) is already a well-known synthetic polymer in tissue engineering due to its biodegradable and biocompatible properties, however, it does not possess intrinsic bioactivity. Many researchers focus on the mixed electrospinning with other bioactivity biopolymers, such as chitosan, silk, sodium alginate, and hyaluronic acid (p. 13, Intro, para. 4). Electrospinning solutions of Chen where prepared with hyaluronic acid (HA) having a molecular weight of 8700 g/mol and PEO (p. 13, Materials and Electrospun solutions). Solutions with PEO/HA ratios of 3/1, 1/1, and 1/3 were prepared and parameters such as conductivity, surface tension, and viscosity were recorded for each solution (Table). The fibers prepared with all three PEO/HA ratios had relatively smooth surfaces and uniform diameters. As the HA content increases, the viscosity of the spinning solution decreases while its conductivity increases. The distributions of the fiber diameter exhibit a decreasing trend (as HA content increases) (p. 14, Results and Discussion, para. 1).
It would have been prima facie obvious to substitute the high molecular weight hyaluronic acid of Vicini with the low molecular weight hyaluronic acid of Chen and to increase its amount as compared to the other components (i.e., alginate and PEO), since such modifications are taught by Chen to decrease the viscosity of the spinning solution. The solutions of Vicini comprising HMW-HA suffer from the problem of having too high a viscosity. Chen teaches that electrospinning solutions comprising low molecular weight HA at a ratio of 3:1 (HA:promoter) result in decreased solution viscosity while also maintaining the ability to form smooth, uniform fibers. Thus, one of ordinary skill in the art would have arrived at the solution of using a low molecular weight HA (i.e., 8700 Da) at a ratio of 3:1 (HA:promoter), as taught by Chen, in the solution of Vicini. One of ordinary skill in the art could have applied the known teachings of Chen to the known electrospinning solution of Vicini, which is ready for improvement, to predictably yield an electrospinning solution with a lower viscosity able to produce smooth and uniform nanofibers.
Additionally, one of ordinary skill in the art would have arrived at the instantly claimed HA:promoter ratio, starting from the ratios taught by Vicini and as informed by the ratios of Chen, through no more than routine experimentation. It would have been well within the abilities of an ordinary artisan to optimize the HA:promoter ratio in the electospinning solution depending on the desired viscosity, spinnability, and conductivity of the solution. As such, one of ordinary skill in the art would have arrived at the instantly claimed HA:promoter ratio of 3:1 through no more than routine experimentation and the teachings of Vicini and Chen. Regarding the ratio of the alginate and PEO as the promotor, Vicini teaches that a ratio of 1:1 is known and routine in the art. Thus, it would have been prima facie obvious to one of ordinary skill in the art to use a 1:1 ratio of alginate and PEO for the promotor and to optimize the ratio of HA:promoter from there. Overall, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since both Vicini and Chen teach adjusting the electrospinning parameters of solutions comprising hyaluronic acid and PEO. Chen discusses that it is known to mix PEO with sodium alginate as well.
Regarding the recitation of “for forming a product that is absorbable by the skin”, the combined composition of Vicini and Chen comprises low molecular weight hyaluronic acid which is highly absorbable by the skin, as evidenced by Sanford Chemicals. Thus, the electrospinning composition of Sandri results in nanofibers comprising highly absorbable hyaluronic acid which would be absorbed by the skin to some extent, thereby reading on the broadest reasonable interpretation of a product that is absorbable by the skin.
Regarding claim 23, Vicini and Chen teach their fibers to be biocompatible and useful for tissue engineering. The recitation of “cosmetic” is simply a recitation of intended use. Statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). Given that the combined composition is biocompatible and can be applied to skin, the recitation of “cosmetic” results in no structural difference between the prior art and the instant invention and does not serve to limit the claim.
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, 8, and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 17/798,028 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims define every element of the instantly claimed invention.
Copending claim 1 of ‘028 recites a composition to be electrospun for forming a product that is absorbable by the skin, comprising a first compound to be electrospun, an electrospinning promoter and at least one active ingredient, wherein said first compound to be electrospun comprises hyaluronic acid; said electrospinning promoter comprises pullulan (copending claim 1). This anticipates every component of instant claim 1.
Copending claim 7 recites a method to prepare a composition to be electrospun, comprising a step of mixing a first compound to be electrospun with an electrospinning promoter, and a step of adding at least one active ingredient, wherein the first compound to be electrospun comprises hyaluronic acid, the electrospinning promoter comprises pullulan and a mixture thereof (copending claim 7). This anticipates every component of instant claim 13.
Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No 17/798,014 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims define every element of the instantly claimed invention.
Copending claim 1 of ‘014 recites a patch product, comprising a membrane substrate absorbable by the skin and at least one active ingredient, wherein said membrane substrate is formed by at least one electrospun fiber comprising hyaluronic acid and an electrospinning promoter, wherein the electrospinning promoter comprises at least one of pullulan and alginate. Such a membrane reads on the cosmetic product of instant claim 23, wherein the fibers could have been obtained by electrospinning a composition according to claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 8, 12, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/798,002 (reference application). Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims.
Copending claim 1 of ‘002 recites a method to produce a packaged cosmetic product comprising a step of electrospinning a composition, in which an electrospun substrate absorbable by the skin is formed. The composition comprises a first compound to be electrospun and a spinning promotor, wherein the first compound to be electrospun comprises hyaluronic acid, and the spinning promoter comprises pullulan or a blend of alginate and poly(oxyethylene). As such, the method of ‘002 makes obvious a composition which reads on the composition of instant claim 1 as well as a product obtained by electrospinning said composition, which reads on claim 23.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 8, 12-13, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/798,008 (reference application) in view of Chen. Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Chen.
Copending claim 1 recites an electrospinning method, comprising: providing a composition to be electrospun to form a membrane substrate able to be absorbed by the skin; wherein said composition to be electrospun comprises a first compound to be electrospun, an electrospinning promoter and an active ingredient, wherein said first compound to be electrospun comprises hyaluronic acid; said electrospinning promoter is at least one selected from pullulan, a mixture of alginate and poly(oxyethylene) having a weight proportion equal to 1:1, and a mixture thereof. As such, ‘008 defines a composition which reads on the composition of instant claim 1 as well as providing said composition, which necessarily comprises mixing as defined in claim 13, and a product obtained by electrospinning said composition, which reads on claim 23.
The ‘008 claims differ from the instant invention in that ‘008 does not explicitly recite a ratio of the compound to be electrospun to the promotor (i.e., PEO + alginate) of 3:1 nor the molecular weight of the hyaluronic acid, as recited in instant claims 21 and 22.
Chen teaches fabricating PEO/HA core-shell nanofibers via homogeneous electrospinning (abstract; p. 13, para. 3, Intro). Electrospun solutions of Chen where prepared with hyaluronic acid (HA) with a molecular weight of 8700 g/mol and PEO (p. 13, Materials and Electrospun solutions). Solutions with PEO/HA ratios of 3/1, 1/1, and 1/3 were prepared and parameters such as conductivity, surface tension, and viscosity were recorded for each solution (Table). The fibers prepared with all three PEO/HA ratios had relatively smooth surfaces and uniform diameters. As the HA content increases, the viscosity of the spinning solution decreases while its conductivity increases. The distributions of the fiber diameter exhibit a decreasing trend (as HA content increases) (p. 14, Results and Discussion, para. 1).
It would have been prima facie obvious to use a hyaluronic acid with a molecular weight of 8700 g/mol (i.e., Da) since such a MW is known and routine in the art as taught be Chen. It would have been further obvious to adjust the HA:promoter weight ratio of ‘008 to increase the amount of low molecular weight HA as compared to the promotor to 3:1, since such an optimization is taught by Chen. Generally, the combination of prior art elements according to known methods to yield predictably results is considered prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 8, 12-13, and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/798,010 (reference application) in view of Chen. Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Chen.
Copending claims ‘010 recite a method to electrospin a composition, comprising: providing a composition to be electrospun to form a membrane substrate able to be absorbed by the skin; wherein said composition to be electrospun comprises a first compound to be electrospun and a spinning promoter, wherein said first compound to be electrospun comprises hyaluronic acid, and said spinning promoter comprises pullulan, a mixture of alginate and poly(oxyethylene) having a weight proportion equal to 1:1, or a mixture thereof. As such, ‘010 defines a composition which reads on the composition of instant claim 1 as well as providing said composition, which necessarily comprises mixing as defined in claim 13, and a product obtained by electrospinning said composition, which reads on claim 23.
The ‘010 claims differ from the instant invention in that ‘008 does not explicitly recite a ratio of the compound to be electrospun to the promotor of 3:1 nor the molecular weight of the hyaluronic acid, as recited in instant claims 21 and 22.
Chen teaches fabricating PEO/HA core-shell nanofibers via homogeneous electrospinning (abstract; p. 13, para. 3, Intro). Electrospun solutions of Chen where prepared with hyaluronic acid (HA) with a molecular weight of 8700 g/mol and PEO (p. 13, Materials and Electrospun solutions). Solutions with PEO/HA ratios of 3/1, 1/1, and 1/3 were prepared and parameters such as conductivity, surface tension, and viscosity were recorded for each solution (Table). The fibers prepared with all three PEO/HA ratios had relatively smooth surfaces and uniform diameters. As the HA content increases, the viscosity of the spinning solution decreases while its conductivity increases. The distributions of the fiber diameter exhibit a decreasing trend (as HA content increases) (p. 14, Results and Discussion, para. 1).
It would have been prima facie obvious to use a hyaluronic acid with a molecular weight of 8700 g/mol (i.e., Da) since such a MW is known and routine in the art as taught be Chen. It would have been further obvious to adjust the HA:promoter weight ratio of ‘010 to increase the amount of low molecular weight HA as compared to the promotor to 3:1, since such an optimization is taught by Chen. Generally, the combination of prior art elements according to known methods to yield predictably results is considered prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/798,019 (reference application) in view of Chen. Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Chen.
Copending claim 1 of ‘019 recites a cosmetic patch product comprising a membrane substrate suitable to be absorbed by the skin, said membrane substrate being made up of at least one electrospun fiber comprising hyaluronic acid and a spinning promoter, wherein the spinning promoter comprises pullulan or a mixture of alginate and polyethylene oxide (PEO) having a weight ratio of 1:1.
The ‘019 claims differ from the instant invention in that ‘019 does not explicitly recite a ratio of the compound to be electrospun to the promotor of 3:1 nor the molecular weight of the hyaluronic acid, as recited in instant claims 21, which is necessary for forming the product of claim 23.
Chen teaches fabricating PEO/HA core-shell nanofibers via homogeneous electrospinning (abstract; p. 13, para. 3, Intro). Electrospun solutions of Chen where prepared with hyaluronic acid (HA) with a molecular weight of 8700 g/mol and PEO (p. 13, Materials and Electrospun solutions). Solutions with PEO/HA ratios of 3/1, 1/1, and 1/3 were prepared and parameters such as conductivity, surface tension, and viscosity were recorded for each solution (Table). The fibers prepared with all three PEO/HA ratios had relatively smooth surfaces and uniform diameters. As the HA content increases, the viscosity of the spinning solution decreases while its conductivity increases. The distributions of the fiber diameter exhibit a decreasing trend (as HA content increases) (p. 14, Results and Discussion, para. 1).
It would have been prima facie obvious to use a hyaluronic acid with a molecular weight of 8700 g/mol (i.e., Da) since such a MW is known and routine in the art as taught be Chen. It would have been further obvious to adjust the HA:promoter weight ratio of ‘019 to increase the amount of low molecular weight HA as compared to the promotor to 3:1, since such an optimization is taught by Chen. Generally, the combination of prior art elements according to known methods to yield predictably results is considered prima facie obvious. Thus the copending claims in combination with Chen teach a cosmetic product obtained by electrospinning the composition according to claim 21, as recited in claim 23.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1 and it’s dependents over Sandri, Peng, and Peng2, individually, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments against claim 21 and it’s dependents over Vicini and Chen have been fully considered but they are not persuasive. Specifically, Applicant argues that Vicini teaches a successful low-molecular-weight HA ternary system used SA/PEO/LMW-HA = 60:30:10, not an HA-rich 6:1:1 composition, and that Chen's binary solution data do not provide a reasonable expectation that adding alginate while preserving alginate:PEO = 1:1 and increasing HA would yield a suitable electrospinning composition (p. 7 of Remarks). In response to this argument, it is discussed in the above rejection that the entirety of Vicini centers around optimizing solution viscosity and electrospinning parameters. Chen teaches methods for optimizing HA/PEO electrospinning solutions containing HA of a specific low molecular weight, specifically as it relates to viscosity. As such, one of ordinary skill in the art would have been able to apply the teachings of Chen to the products of Vicini to experiment with the proportions between the polymers thereby yielding an optimized electrospinning solution. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). Regarding the reasonable expectation of success, an absolute expectation is not required, only a reasonable one. Given that Vicini and Chen both teach methods of optimizing viscosity and other electrospinning parameters for polymers such as hyaluronic acid, PEO, and alginate, it is very likely that one of ordinary skill could combine their teachings through routine optimization with a reasonable expectation of success.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 9-5 (Flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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