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 .
DETAILED ACTION
The Applicant’s reply filed on 7/1/26 is acknowledged. Claims 1-6, 8-11, 13-19, 23, 25 and 27 are pending. Claims 19, 25 and 27 have been withdrawn. Claims 1, 2, 11, 14-18 and 23 have been amended. Claims 1-6, 8-11, 13-18 and 23 are under consideration.
Objections Withdrawn
The objections of claims 1 and 23 are withdrawn in view of the claims.
Rejections Withdrawn
The rejection of Claims 1-6, 8-11, and 13-18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amended claim(s).
The rejection of Claims 1-6, 8-11, and 13-18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of the amended claim(s).
The rejection of Claims 1, 6, 8-11, 13, 15-18 and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (WO 2020/185654; cited in IDS) is withdrawn in view of the amended claim(s).
Rejections Maintained and New Grounds of Rejections
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 5/14/26 and 7/1/26. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim 3 is 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.
Claim 3 recites “the polysaccharide” in line 1. It is unclear if this refers to the polysaccharide comprising inulin recited in claim 1, or the “non-inulin” polysaccharide recited in Claim 2, since the polysaccharides in the Markush group that follow comprise both inulin and non-inulin polysaccharides. Since it is unclear how many polysaccharides, and which ones, are required as part of the intimate care composition the claim is indefinite.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-11, 13-18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2020/185654; cited in IDS) in view of Mitchell et al. (US 2020/0129405).
Li et al. disclose personal care compositions comprising a complex comprising a plurality of short chain fatty acids (e.g. abstract). Li et al. further teach that their compositions comprise a biomimetic blend which inhibits harmful bacteria, while promoting the growth of beneficial bacteria (e.g. paragraphs 0002, 0007). Li et al. exemplify a composition comprising post-biotic blend comprising a total of 0.608 wt% combined of pyruvic acid, lactic acid, and acetic acid (e.g. Example 1).
Li et al. teach that the compositions may be personal care compositions including a hair care composition, a shampoo, or a hair conditioner (e.g. paragraph 0040). They do not teach the inclusion of inulin or 2-butyloctanol. This is made up for by the teachings of Mitchell et al.
Mitchell et al. disclose hair treatment compositions that are particularly useful for improving the quality of hair (e.g. paragraph 0001). Mitchell et al. disclose the composition comprises:
- about 1-5 wt% of inulin (i.e. a polysaccharide) (e.g. Example 1 and Claim 1);
- one or more oils, including 2-butyloctanol (i.e. fatty alcohol) (e.g. paragraph 0130); and
- about 0.5-20 wt% of one or more acids, including lactic acid (e.g. Claim 7, Example 1).
Regarding Claims 1, 4-6, 8-11, 13, 15-18, and 23, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the biomimetic blend of Li et al. with the hair care compositions of Mitchell et al., comprising inulin and 2-butyloctanol. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions are hair treating compositions comprising lactic acid, and one of ordinary skill would have been motivated because Li et al. specifically teaches the inclusion of the biomimetic compositions in hair care compositions but does not provide details of the final composition. One of ordinary skill in the art would have sought out an appropriate hair care composition. In addition, one would have been motivated to obtain the benefits associated with the biomimetic composition which inhibits harmful bacteria, while promoting the growth of beneficial bacteria.
Regarding Claims 2, 3, and 14, Mitchell et al. further teach the inclusion of hydroxyethyl cellulose and fructooligosaccharides (e.g. paragraphs 0074-0076, 0113, 0116, 0118).
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 8-11, 13-18 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, 13-18, 25, 32 and 33 of copending Application No. 18/458,702 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a composition comprising from about 0.5 to about 7 wt.% of a post-biotic blend (copending Claim 1). Regarding the limitation “wherein the composition inhibits the growth of G. vaginalis by about 5% or more and increases the growth of L. crispatus by about 5% or more by counting CFU/mL after incubating a 2 ml of a bacterial culture having a 0.1 optical density at 610 nm using a UV-VIS Spectrometer for G. vaginalis and L. crispatus with a 2 ml of 1% personal care product at a temperature of 37 °C for 3 hours” this is a feature inherent to the post-biotic composition. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim 1 and 15-18 are met by copending Claim 1.
Claim 2 is met by copending Claim 2.
Claim 3 is met by copending Claim 3.
Claims 4 is met by copending Claim 4.
Claim 5 is met by copending Claim 5.
Claim 6 is met by copending Claim 6.
Claim 8 is met by copending Claim 8.
Claims 9 and 23 are met by copending Claim 9.
Claim 10 is met by copending Claim 10.
Claim 11 is met by copending Claim 1.
Claim 13 is met by copending Claim 13.
Claim 14 is met by copending Claim 14
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8-11, 13-18 and 23 are directed to an invention not patentably distinct from claims 1-6, 8-11, 13-18, 25, 32 and 33 of commonly assigned 18/458,702. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/458,702, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-6, 8-11, 13-18 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-48 and 50-52 of copending Application No. 18/544,750 (reference application) and in view of Mitchell et al. (US 2020/0129405).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a composition comprising from about 0.5 to about 7 wt.% of a post-biotic blend (copending Claim 1). Regarding the limitation “wherein the composition inhibits the growth of G. vaginalis by about 5% or more and increases the growth of L. crispatus by about 5% or more by counting CFU/mL after incubating a 2 ml of a bacterial culture having a 0.1 optical density at 610 nm using a UV-VIS Spectrometer for G. vaginalis and L. crispatus with a 2 ml of 1% personal care product at a temperature of 37 °C for 3 hours” this is a feature inherent to the post-biotic composition. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim 1, 6, and 8-10, 15-18 and 23 are met by copending Claim 1.
They do not teach the inclusion of inulin or 2-butyloctanol. This is made up for by the teachings of Mitchell et al.
Mitchell et al. disclose hair treatment compositions that are particularly useful for improving the quality of hair (e.g. paragraph 0001). Mitchell et al. disclose the composition comprises:
- about 1-5 wt% of inulin (i.e. a polysaccharide) (e.g. Example 1 and Claim 1);
- one or more oils, including 2-butyloctanol (i.e. fatty alcohol) (e.g. paragraph 0130); and
- about 0.5-20 wt% of one or more acids, including lactic acid (e.g. Claim 7, Example 1).
Regarding Claims 2-5 and 14, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the post-biotic blend of ‘750 with the hair care compositions of Mitchell et al., comprising inulin and 2-butyloctanol. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions comprise lactic acid. In addition, one would have been motivated to obtain the benefits associated with the post-biotic blend of ‘750 which inhibits harmful bacteria, while promoting the growth of beneficial bacteria.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8-11, 13-18 and 23 are directed to an invention not patentably distinct from claims 43-48 and 50-52 of commonly assigned 18/544,750. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/544,750, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-6, 8-11, 13-18 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-11, 13, 14, 25-31 of copending Application No. 18/977,205 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a composition comprising from about 0.5 to about 7 wt.% of a post-biotic blend (copending Claim 1). Regarding the limitation “wherein the composition inhibits the growth of G. vaginalis by about 5% or more and increases the growth of L. crispatus by about 5% or more by counting CFU/mL after incubating a 2 ml of a bacterial culture having a 0.1 optical density at 610 nm using a UV-VIS Spectrometer for G. vaginalis and L. crispatus with a 2 ml of 1% personal care product at a temperature of 37 °C for 3 hours” this is a feature inherent to the post-biotic composition. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim 1 and 15-18 are met by copending Claim 1.
Claim 2 is met by copending Claim 2.
Claim 3 is met by copending Claim 3.
Claims 4 and 5 are met by copending Claim 4.
Claim 6 is met by copending Claim 6.
Claim 8 is met by copending Claim 8.
Claims 9 and 23 are met by copending Claim 9.
Claim 10 is met by copending Claim 10.
Claim 11 is met by copending Claim 1.
Claim 13 is met by copending Claim 13.
Claim 14 is met by copending Claim 14
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8-11, 13-18 and 23 are directed to an invention not patentably distinct from claims 1-4, 6, 8-11, 13, 14, 25-31 of commonly assigned 18/977,205. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/977,205, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-6, 8-11, 13-18 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,201,713.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a composition comprising from about 0.5 to about 7 wt.% of a post-biotic blend (copending Claim 1). Regarding the limitation “wherein the composition inhibits the growth of G. vaginalis by about 5% or more and increases the growth of L. crispatus by about 5% or more by counting CFU/mL after incubating a 2 ml of a bacterial culture having a 0.1 optical density at 610 nm using a UV-VIS Spectrometer for G. vaginalis and L. crispatus with a 2 ml of 1% personal care product at a temperature of 37 °C for 3 hours” this is a feature inherent to the post-biotic composition. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1-3, 6, 8-10, 15-18 and 23 are met by patented Claim 1.
Claims 4 and 5 are met by patented Claim 4.
Claim 11 is met by patented Claim 1.
Claim 13 is met by patented Claim 10.
Claim 14 is met by patented Claim 4
Claims 1-6, 8-11, 13-18 and 23 directed to an invention not patentably distinct from claim 1-17 of commonly assigned 12,201,713. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 12,201,713, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicant's arguments filed 7/1/26 have been fully considered but they are not persuasive.
Applicant argues that Mitchell fails to motivate, teach or fairly suggest adding both his fatty alcohols and his inulin (which are intended for hair treatment) into Li's intimate care composition.
This is not found persuasive. It would have been obvious to one of ordinary skill in the art at the time of filing to combine the biomimetic blend of Li et al. with the hair care compositions of Mitchell et al., comprising inulin and 2-butyloctanol. One of ordinary skill in the art would have predicted success as both of the compositions are hair treating compositions comprising lactic acid, and one of ordinary skill would have been motivated because Li et al. specifically teaches the inclusion of the biomimetic compositions in hair care compositions but does not provide details of the final composition. One of ordinary skill in the art would have sought out an appropriate hair care composition. In addition, one would have been motivated to obtain the benefits associated with the biomimetic composition which inhibits harmful bacteria, while promoting the growth of beneficial bacteria.
Applicant further argues that Applicant's Ex. C (a personal care composition in the form of an intimate care composition and contained lactic acid, sodium pyruvate, inulin, and butyloctanol) reduced the growth of G. vaginalis more than Ex. D. (a similar formulation as Ex. C, except that Ex. D did not include inulin and butyloctanol).
This is not found persuasive.
First, the full formulation is not provided, so the Examiner is unable to determine how the tested composition compares to the instant claims. Claim 1 requires 0.05-7 wt% of a post-biotic blend, but the percentage of Ex. C and D is not disclosed.
Second, the claims are much broader than the tested composition, both in terms of ingredients and amounts thereof. It is unclear if the same effect would be seen for all concentrations and structures within the scope of the claims. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Third, Applicant has not compared to the closest prior art, which is the composition of Mitchell which comprises about 1-5 wt% of inulin (i.e. a polysaccharide) (e.g. Example 1 and Claim 1); one or more oils, including 2-butyloctanol (i.e. fatty alcohol) (e.g. paragraph 0130); and about 0.5-20 wt% of one or more acids, including lactic acid (e.g. Claim 7, Example 1). An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979) (see MPEP 716.02(e)).
Fourth, the data do not appear to be surprising. Ex. C appears to reduce the growth of G. vaginalis slightly more than Ex D, but the error bars overlap and Figure 6B does not show a statistical difference between Ex. C and Ex. D. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
Accordingly, the rejections are maintained.
Conclusion
No claim is 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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