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
Claims 1-6, 8-11, 13-19, 23, 25 and 27 are pending.
Election/Restrictions
Applicant’s election of the Invention of Group I, claims 1-6, 8-11, 13-18, 23, 25 and 27, and the species of a) the presence of a polysaccharide and b) the presence of a fatty alcohol, in the reply filed on 12/18/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claim 19 is withdrawn as being drawn to a nonelected invention.
Claims 25 and 27 are withdrawn as not being directed to the elected species.
Claims 1-6, 8-11, 13-18 and 23 are under consideration to the extent that the composition comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 9/16/23, 1/23/24, 5/17/24, 6/26/25, and 2/16/26. 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 Objections
Claims 1 and 23 are objected to because of the following informalities:
In claim 1, line 2, “the personal are care composition” appears to be a typo of “the personal
In claim 23, “lactic acid” and “pyruvic acid” are each listed twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-6, 8-11, and 13-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition comprising the ingredients of Compositions C and D of the Specification which 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, does not reasonably provide enablement for “0.5-7 wt% of a post-biotic blend” providing the claimed effect. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), "There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." The criteria for determining such undue experimentation, summarized in In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988), are: (1) the nature of the invention; (2) the breadth of the claims; (3) the amount of direction or guidance presented; (4) the presence or absence of working examples; (5) the state of the prior art; (6) the predictability or unpredictability of the art; (7) the relative skill of those in the art; and (8) analysis of the quantity of experimentation necessary. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
Regarding factors (1)-(2), instant claim 1, when given the broadest possible interpretation, encompasses a composition comprising 0.5-7 wt% of a “post-biotic blend” such that the claimed growth of G. vaginalis and of L. crispatus is met as tested under a specific set of criteria. Instant claims 6, 8-10, 13, 14 and 23 further define the post-biotic blend. Claims 2-5 and 11 further define additional ingredients present in the composition. Claims 15-18 include additional bacteria growth counts and testing.
Regarding factors (3)-(4), the specification provides insufficient data to enable claims directed to intimate care composition as instantly claimed. That is, the Specification does not define “post-biotic blend” and broadly teaches several short-chain fatty acids (see paragraphs 0074-0103) and further teach various additional ingredients (see paragraphs 0064-0073, 0104-0150). The Specification further discloses “the inventors discovered that personal care compositions formulated to have specific components in certain ratios provide synergistic benefits to the skin microbiome, including, e.g., reducing undesirable bacteria and increasing desirable bacteria” (e.g. paragraph 0007). However, Applicant demonstrates only two compositions (Compositions C and D) which appear to provide the claimed G. vaginalis inhibition and L. crispatus growth (see Examples 6 and 7 on pages 49-50 and Figures 6A, 6B and 6C). The concentration and ratios of the ingredients are not provided (see paragraph 00173). However, no other specific teachings are provided of any other combination of post-biotic blend and additional ingredients. As a result, the specification provides inadequate guidance to allow the skilled artisan to determine, without undue experimentation, what other “post-biotic blend” would inhibit the growth of G. vaginalis by about 5% or more and increase 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. Therefore, the broad aspects of the composition are not reasonably enabled for the full scope embraced by the claimed invention.
Regarding factors (5)-(7), in relation to role of the post-biotic blends and short-chain fatty acids in bacteria growth, Wu et al. teach that G. vaginalis is associated with bacterial vaginosis (BV), and vaginal fluids in BV are characterized by higher concentrations of short chain fatty acids, such as acetate, propionate, butyrate, and succinate, while L. crispatus, produce lactic acid, which may provide protection against bacterial vaginosis (BV) (e.g. page 1, column 2; Figure 1; page 2, column 2). It is noted that the fatty acids acetate, propionate, butyrate, and succinate are recited in the instant Specification and Claims as suitable short-chain fatty acids for use in the post-biotic blend (see claim 8). Wu et al. demonstrate that not all post-biotic blends or short-chain fatty acids would inhibit the growth of G. vaginalis. Therefore, the instant claimed invention is highly unpredictable since one skilled in the art, using Applicants preferred composition ingredients would not arrive at the claimed bacterial growth and inhibition.
Regarding factor (8), as set forth above, neither the prior art of record nor the as-filed specification provides sufficient guidance to enable a person skilled in the art to employ a post-biotic blend or composition of short-chain fatty acids other than Compositions C and D to achieve inhibition of the growth of G. vaginalis by about 5% or more and increased 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. There is no evidence that the claimed bacteria counts are achieved by any other post-biotic blend, and Wu et al. provides evidence to the contrary. As the result, given the unpredictability of the art and the lack of sufficient working examples in the instant specification, particularly when taken with the numerous possible combinations of disclosed ingredients, it would have required undue experimentation to practice the instant composition as broadly or generically claimed.
In light of the foregoing, the claimed invention is not enabled for post-biotic blends.
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 1-6, 8-11, and 13-18 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation " the personal are care composition" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “An intimate care composition”. Claims 2-6, 8-11, and 13-18 are rejected as depending from and not clarifying Claim 1.
Claim 1 recites the limitation " personal care product" in line 6. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “An intimate care composition”. Claims 2-6, 8-11, and 13-18 are rejected as depending from and not clarifying Claim 1.
Claim 11 recites the limitation " the personal are care composition" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “An intimate care composition”.
Claim 14 recites the limitation " the fatty alcohol" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from claim 2, which does not recite a fatty alcohol.
Claim 15 recites the limitation " intimate care product" in line 6. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “An intimate care composition”.
Claim 16 recites the limitation " intimate care product" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “An intimate care composition”.
Claim 18 recites the limitation " intimate care product" in line 6. There is insufficient antecedent basis for this limitation in the claim. The claim previously recites “An intimate care composition”.
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.
Claims 1, 6, 8-11, 13, 15-18 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (WO 2020/185654; cited in IDS).
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).
Regarding Claims 1, 6, 8, 9, and 23, 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).
Regarding the preamble “an intimate care composition” 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. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999) (see MPEP 2111.02VII). In the instant case the composition requires only the presence of 0.5- 7wt% of a post-biotic blend, which is met by Example 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).
Regarding Claim 10, Li et al. exemplify a ratio of lactic acid to pyruvate of 4.32:1, which is within the claimed range (e.g. Example 1).
Regarding Claim 11, the composition is free of caffeine and mandelic acid (e.g. Example 1).
Regarding Claim 13, the blend was prepared as a byproduct of Lactobacillus rhamnosus (e.g. Example 1).
Regarding Claims 15-18, the instant Specification does not disclose how the composition is formulated to inhibit and increase the growth as claimed, other than through inclusion of the claimed ingredients. “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). In the instant case the composition of Li et al. comprises a post-biotic blend comprising the claimed short chain fatty acids in the claimed ratio, therefore the claims are met.
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).
Regarding Claims 1, 6, 8-11, 13, 15-18 and 23, the teachings of Li et al. are described supra.
Li et al. 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. 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 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 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.
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.
Conclusion
No claim is allowed.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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