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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16634163, filed on 01/27/2020
This Application is a CON of 17169403 filed 02/06/2021 (ABN).
17169403 is a CON of 16634163 filed 01/27/2020 (PAT 10980740).
16634163 is a 371 of PCT/IB2018/056900 filed 09/11/2018.
This Application also claims foreign priority benefit of INDIA IN201741032141 filed 09/12/2017.
However, the following subject matters are not present in parent applications 17169403 and 16634163, as well as, 371 application of PCT/IB2018/056900 and foreign application of INDIA IN201741032140:
“the tranexamic acid and the chitosan are present in ratio of at least about 2.5:1” (claim 11)
“the tranexamic acid and the chitosan are present in ratio of at least about 10:1” (claim 12)
“the tranexamic acid and the chitosan are present in ratio of at least about 50:1” (claim 13)
“about 0.2% w/w chitosan” (claim 15)
“the tranexamic acid and the chitosan are present in ratio of at least about 2.5:1” (claim 17)
“the tranexamic acid and the chitosan are present in ratio of at least about 10:1” (claim 18)
“the tranexamic acid and the chitosan are present in ratio of at least about 50:1” (claim 19)
“about 0.2% w/w chitosan” (claim 30).
“about 15 minutes” for filtering of the composition (claim 29)
Thus, claims 11-19 and 29-30 will not receive priority filing date benefits of the parent applications 17169403 and 16634163, the 371 application of PCT/IB2018/056900 and the foreign priority application of INDIA IN201741032140.
Accordingly, claims 11-19 and 29-30 are afforded the effective filing date of 09/17/2024 (actual filing date); and claims 20-28 are afforded the effective filing date of 09/12/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/20/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 11-19 and 30 drawn to a topical spray composition, in the reply filed on 06/02/2026 is acknowledged.
Claims 20-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups/inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2026.
Status of the Claims
This action is in response to preliminary papers filed 09/17/2024 in which claims 1-10 were canceled; and claims 11-30 were newly added. All the amendments have been thoroughly reviewed and entered.
Claims 11-30 are pending in this instant application, of which claims 20-29 are withdrawn at this time being drawn to a nonelected groups/inventions.
Claims 11-19 and 30 are examined herein on the merits for patentability.
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-19 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 11-13, 15, 17-19 and 30 introduce new matter as the claims recite the following limitations:
“the tranexamic acid and the chitosan are present in ratio of at least about 2.5:1” (claim 11)
“the tranexamic acid and the chitosan are present in ratio of at least about 10:1” (claim 12)
“the tranexamic acid and the chitosan are present in ratio of at least about 50:1” (claim 13)
“about 0.2% w/w chitosan” (claim 15)
“the tranexamic acid and the chitosan are present in ratio of at least about 2.5:1” (claim 17)
“the tranexamic acid and the chitosan are present in ratio of at least about 10:1” (claim 18)
“the tranexamic acid and the chitosan are present in ratio of at least about 50:1” (claim 19)
“about 0.2% w/w chitosan” (claim 30).
There is no support in the specification for the aforementioned limitations.
Applicant asserted that support for new claims 11-19 and 30 can be found in at least page 7, lines 12-16, page 8, lines 3-5, and Examples 1, 2, 4, and 5 in the application as-filed (Remarks filed 09/17/2024, page 6).
. However, after a thorough review of said page 7, lines 12-16, page 8, lines 3-5, and Examples 1, 2, 4, and 5 of the specification, there appeared to be no support for the broadly claimed ratio ranges for tranexamic acid and chitosan as recited in claims 11-13 and 17-19, as well as, no support for the amount of “about 0.2% w/w chitosan as recited in claims 15 and 30.
It is noted that page 7, lines 12-16 is drawn to disclosing: topical spray composition comprises tranexamic acid from about 1 % to about 10% of tranexamic acid based on the total weight of the composition, and more preferably 1% w/w, 1.5% w/w, 2% w/w, 2.5% w/w, 3% w/w, 3.5% w/w, 4% w/w, 4.5% w/w, 5% w/w, 5.5% w/w, 6% w/w, 6.5% w/w, 7% w/w, 7.5% w/w, 8% w/w, 8.5% w/w, 9.5% w/w and 10% w/w.
It is noted that page 8, lines 3-5 is drawn to disclosing: chitosan is preferably used in the pharmaceutical spray composition of about 0.1% to about 1% based on the total weight of the composition
However, the disclosures from page 7, lines 12-16 and page 8, lines 3-5 do not provide support for the broad ratio ranges for tranexamic acid and chitosan as recited in claims 11-13 and 17-19 because the broad claimed ratio ranges of “at least about 2.5:1,” “at least about 10:1,” and “at least about 50:1” encompassed a ratio from 2.5:1, 10:1, or 50:1 to an infinite ratio number that includes for example 200:1 and 500:1, which clearly not supported by the weight % amounts as disclosed in page 7, lines 12-16 and page 8, lines 3-5, respectively for tranexamic acid and chitosan.
With respect to Examples 1, 2, 4, and 5 of the specification, it is noted that the Tables in Examples 1, 2, 4, and 5 disclosed weight % amounts for tranexamic acid and chitosan that are in line with the aforementioned disclosures from page 7, lines 12-16 and page 8, lines 3-5. Thus, same as page 7, lines 12-16 and page 8, lines 3-5, Examples 1, 2, 4, and 5 of the specification do not provide support for the broad ratio ranges for tranexamic acid and chitosan as recited in claims 11-13 and 17-19 because the broad claimed ratio ranges of “at least about 2.5:1,” “at least about 10:1,” and “at least about 50:1” encompassed a ratio from 2.5:1, 10:1, or 50:1 to an infinite ratio number that includes for example 200:1 and 500:1, which clearly not supported by the weight % amounts as disclosed in Examples 1, 2, 4, and 5.
With respect the claimed amount of “about 0.2% w/w chitosan as recited in claims 15 and 30, it is noted that nowhere on page 7, lines 12-16, page 8, lines 3-5 or Examples 1, 2, 4, and 5 do they provide support or disclosed disclosure for chitosan to be particularly about 0.2% w/w as claimed.
Claims 14 and 16 are also rejected as they depend directly from claim 11, thereby also contains the new matter material.
Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matters as amended at the time of filing of the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 11-13 and 17-19, the recitation “at least about” in said claims indefinite 11-13 and 17-19 is indefinite. The phrase “at least” typically indicates a minimum point; however, the phrase “at least” is controverted by the term “about,” which implies that values above and below the indicated amount are permitted. Therefore, the juxtaposition of these two terms makes it unclear what maximum dimensions are encompassed by the claim. In Amgen, Inc. v. Chugai Pharmaceutical co., 927 F.2d 1200 (CAFC 1991), the CAFC stated, “[t]he district court held claims 4 and 6 of the patent invalid because their specific activity of “at least about 160,000” was indefinite.” After review, the CAFC states “[w]e therefore affirm the district court’s determination on this issue.” Thus, the CAFC found the phrase “at least about” indefinite where the metes and bounds of the term were not defined in the specification.
Claims 14-16 are also rejected as they depend from indefinite claim 11.
As a result, claims 11-19 do not clearly set for the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 102
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.
Claim(s) 11-14 and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rangabhatla Gunneswara Subramanya et al (US 2020/0230047 A1; hereafter as “Subramanya”).
Regarding claim 11, Subramanya teaches a topical spray composition comprising about 1% w/w to about 10% w/w tranexamic acid, about 0.1% w/w to about 1% w/w chitosan, and water (Abstract; [0023]-[0094]; Examples 2-5; claims 1-10). Subramanya teaches the spray composition contains tranexamic acid and chitosan at a weight ratio from 10:1 to 100:1 (i.e., 10% w/w tranexamic and 0.1-1.0% w/w chitosan) (Examples 2-5), which reads on the claimed range of “at least about 2.5:1.”
Regarding claim 12, as discussed above, Subramanya teaches the spray composition contains tranexamic acid and chitosan at a weight ratio from 10:1 to 100:1 (i.e., 10% w/w tranexamic and 0.1-1.0% w/w chitosan) (Examples 2-5)., which reads on the claimed range of “at least about 10:1.”
Regarding claim 13, as discussed above, Subramanya teaches the spray composition contains tranexamic acid and chitosan at a weight ratio from 10:1 to 100:1 (i.e., 10% w/w tranexamic and 0.1 % w/w chitosan) (Examples 2-5), which reads on the claimed range of “at least about 50:1.”
Regarding claim 14, Subramanya teaches the spray composition contains 10% w/w tranexamic acid and 0.1- 1.0% w/w chitosan ([0040], [0051]-[0063]; Examples 4-5).
Regarding claim 16, Subramanya teaches the spray composition further contains glacial acetic acid (Abstract; [0023]-[0094]; Examples 2-5; claims 1-10).
Regarding claim 17, Subramanya teaches a topical spray composition comprising about 1% w/w to about 10% w/w tranexamic acid, about 0.1% w/w to about 1% w/w chitosan, water, and glacial acetic acid (Abstract; [0023]-[0094]; Examples 2-5; claims 1-10). Subramanya teaches the spray composition contains tranexamic acid and chitosan at a weight ratio from 10:1 to 100:1 (i.e., 10% w/w tranexamic and 0.1-1.0% w/w chitosan) (Examples 2-5), which reads on the claimed range of “at least about 2.5:1.”
Regarding claim 18, as discussed above, Subramanya teaches the spray composition contains tranexamic acid and chitosan at a weight ratio from 10:1 to 100:1 (i.e., 10% w/w tranexamic and 0.1-1.0% w/w chitosan) (Examples 2-5)., which reads on the claimed range of “at least about 10:1.”
Regarding claim 19, as discussed above, Subramanya teaches the spray composition contains tranexamic acid and chitosan at a weight ratio from 10:1 to 100:1 (i.e., 10% w/w tranexamic and 0.1 % w/w chitosan) (Examples 2-5), which reads on the claimed range of “at least about 50:1.”
As a result, the aforementioned teachings from Subramanya are anticipatory to claims 11-14 and 16-19 of the instant invention.
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.
Claim(s) 11-19 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rangabhatla Gunneswara Subramanya et al (US 2020/0230047 A1; hereafter as “Subramanya”).
The topical spray compositions of claims 11-14 and 16-19 are discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 15 and 30, Subramanya teaches a topical spray composition containing 10% w/w tranexamic and 0.1-1.0% w/w chitosan ([0040], [0051]-[0063]; Examples 4-5; claims 1-5).
It would have been obvious to one of ordinary skill in the art to optimize the weight amount of chitosan in the topical spray composition to an amount of about 0.2% w/w, and achieve the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Subramanya teaches the weight amount of chitosan can be optimize from 0.1 to 1.0% w/w, which is a range that encompassed the claimed amount of “about 0.2% w/w” for chitosan. Thus, absent some demonstration of unexpected results showing criticality from the claimed weight % amount, the optimization of weight % amount of chitosan in the topical spray composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Claim(s) 11-19 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mousa et al (21 July 2016; US 2016/0206773 A1; cited in IDS filed 11/20/2024) in view of Manoryk et al (26 August 2016; WO 2016/133483 A1; cited in IDS filed 11/20/2024).
Regarding claims 11, 17 and 30, Mousa teaches a topical composition in the form of a spray comprising tranexamic acid, chitosan, acetic acid, and water, wherein the topical composition is an aqueous solution (Abstract; [0033], [0050], [0059], [0061]-[0063], [0068], [0077]-[0079] and [0095]; claims 1, 7 and 11).
However, Mousa does not teach the amounts of tranexamic acid and chitosan of claims 11, 17 and 30, Manoryk teaches a topical composition comprising an organic hemostatic agent such as tranexamic acid and a water retaining hemostatic agent such as chitosan, wherein the topical composition is in the form of spray, and wherein the tranexamic acid is present in the composition in an amount of from 0.001% to 50% by weight and chitosan is present in an amount of from 0.001% to 30% by weight (pages 2-5, 29, 60-61, and 78; claims 1-3).
It would have been obvious one of ordinary skill in the art to optimize the concentrations of tranexamic acid and chitosan in the topical composition of Mousa to the weight amounts and ratios as claimed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Mousa and Manoryk are commonly drawn to topical compositions comprising tranexamic acid and chitosan, wherein the topical composition is used as hemostatic product (Mousa: [0053]; Manoryk: pages 2-5, 29, and 60-61; claims 1-3), and Manoryk provided the guidance for optimizing the concentrations of tranexamic acid to an amount of from 0.001% to 50% by weight and chitosan to an amount of from 0.001% to 30% by weight, which overlaps the claimed ranges of about 1% w/w to about 10% w/w for tranexamic acid and about 0.1% w/w to about 1% w/w for chitosan, as well as, the weight ratio of at least about 2.5:1 for tranexamic acid and chitosan as recited in claims 11 and 17. Furthermore, the weight amounts ranges for tranexamic acid and chitosan as taught in Manoryk supra also encompassed the claimed amount of “about 10% w/w tranexamic acid” and “about 0.2% w/w chitosan” as recited in claim 30. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of tranexamic acid and chitosan, as well as, the weight ratios of tranexamic acid and chitosan in a topical spray composition would have been obvious before the effective filing date of Applicant’s invention. Furthermore, [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, 105 USPQ 233 (CCPA 1955). See MPEP 2144.05 (I)-(II).
Regarding claims 12-13 and 18-19, as discussed above, Manoryk provided the guidance for optimizing the concentrations of tranexamic acid to an amount of from 0.001% to 50% by weight and chitosan to an amount of from 0.001% to 30% by weight, which overlaps the claimed weight ratio ranges “at least about 10:1 for tranexamic acid and chitosan” and “at least about 50:1 for tranexamic acid and chitosan” as recited respectively of claims 12-13 and 18-19. As discussed above, absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight ratios of tranexamic acid and chitosan in a topical spray composition would have been obvious before the effective filing date of Applicant’s invention. Furthermore, [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, 105 USPQ 233 (CCPA 1955). See MPEP 2144.05 (I)-(II).
Regarding claim 14, as discussed above, Manoryk provided the guidance for optimizing the concentrations of tranexamic acid to an amount of from 0.001% to 50% by weight and chitosan to an amount of from 0.001% to 30% by weight, which overlaps the claimed range of from about 0.1% w/w to about 1% w/w chitosan, as well as, the weight amount range for tranexamic as taught by Manoryk also encompassed the claimed amount of “about 10% w/w tranexamic acid.” Thus, as discussed above, absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of tranexamic acid and chitosan in a topical spray composition would have been obvious before the effective filing date of Applicant’s invention. Furthermore, [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, 105 USPQ 233 (CCPA 1955). See MPEP 2144.05 (I)-(II).
Regarding claim 15, as discussed above, Manoryk provided the guidance for optimizing the concentrations of tranexamic acid to an amount of from 0.001% to 50% by weight and chitosan to an amount of from 0.001% to 30% by weight, which encompassed the claimed amount of “about 10% w/w tranexamic acid” and “about 0.2% w/w chitosan.” As discussed above, absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight amounts of tranexamic acid and chitosan in a topical spray composition would have been obvious before the effective filing date of Applicant’s invention. Furthermore, [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, 105 USPQ 233 (CCPA 1955). See MPEP 2144.05 (I)-(II).
Regarding claim 16, as discussed above, Mousa teaches the topical composition in the form of a spray comprises tranexamic acid, chitosan, acetic acid, and water.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 11-19 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10980740.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent significantly overlap with the subject matter of instant claims, i.e., topical spray compositions containing about 1% w/w to about 10% w/w tranexamic acid, about 0.1% w/w to about 1% w/w chitosan, glacial acetic acid and water.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over U.S. Patent No 10980740.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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