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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/12/26 has been entered.
Claims Status
Applicants’ amendment filed August 12, 2026, is acknowledged. Claims 17-23, 25-29, 31-32, 38-39 have been amended. Claims 40-41 have been withdrawn. Claim 42 is new. Claims 1-16, 24 and 33-37 have been canceled. Claims 17-23, 25-32, 38-39 and 42 are under examination.
Rejections Withdrawn
The following are withdrawn from the Office Action filed August 12, 2026, based on Applicant’s arguments.
a. The rejection of claim 22 under 35 U.S.C. 112(a), pages 4-7 of the previous Office action.
b. The rejection of claims 21, 26, 28, 29 and 32 under 35 U.S.C. 112(b), page 7 of the previous Office action.
c. The rejection of claims 17-23, 25-32 and 38-39 under 35 U.S.C.102(a)(1), pages 8-10 of the previous Office action.
d. The rejection of claims 17-23, 25-32 and 38-39 under 35 U.S.C. 102(a)(1), pages 10-13 of the previous Office action.
e. The rejection of claims 17-23, 25-32 and 38-39 under 35 U.S.C. 103(a), pages 13-17 of the previous Office action.
Trademarks
The use of the term for example, Collguard™ which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Please, review the specification, for other trademarks. 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.
Written Description
Claims 17-23, 25-32, 38-39 and 42 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
The instant claims are drawn to a method comprising administering a strain of Lactobacillus crispatus deposited under the designation CNCM I-5579, or a dermatological composition comprising it, for treating or preventing pathologies of the skin
The specification discloses the present invention relates to the cosmetic, nutraceutical and/or pharmaceutical, notably dermatological, use of a strain of Lactobacilus crispatus and/or a composition comprising it for maintaining and/or increasing the expression of extracellular matrix molecules of the skin and/or of the mucous membranes and notably for maintaining and/or increasing the biomechanical properties of healthy skin and/or healthy mucous membranes, preferentially the firmness and/or elasticity and/or density of healthy skin and/or healthy mucous membranes, even more preferentially the firmness and/or elasticity of healthy skin and/or healthy mucous membranes. The specification provides example 2 which teaches the increase in the expression of type I collagen by fibroblasts in the presence of L. crispatus strain, example 3 which teaches increase in the expression of proteins fibulin-5 and emillin-1 involved in the formation of elastic fibers by fibroblasts in the presence of the strain of L. crispatus and example 4 which teaches in vivo measurement of the increase in skin elasticity in the presence of the strain of L. crispatus. Example 4, results show the beneficial effect of the formulated L. crispatus strain in particular its secretome for maintaining and /or increasing in vivo the biomechanical properties of healthy skin and/or healthy mucous membranes in particular the elasticity of healthy skin and/or healthy mucous membranes. Example 5 discloses the in vivo measurement of the increase in skin density in the presence of strain L. crispatus.
However, the claims broadly encompass administering a strain of Lactobacillus crispatus, or a dermatological composition comprising it, for treating or preventing any pathologies of the skin. A review of the state of the art discloses that L. crispatus can cause side effects such as symptoms of serious allergic reactions that include itching or rash, bumps on the skin called hives that can be red, pink, white, or brown depending on your tone. See Chelsey McIntyre, Lactobacillus Crispatus: Overview, Uses, Side Effects, Precautions, Interactions, Dosing and Reviews, March 27, 2026.
Thus, the state of the art has disclosed that all Lactobacillus crispatus cannot be used to treat or prevent pathologies of the skin. In fact, some L. crispatus can cause adverse effects on the skin the deposited strain of L. crispatus merely teaches that elasticity is increased and skin density after application.
Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that
"applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow a person of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
The skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
The claimed invention may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function (see MPEP 2163). A patent specification must set forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed. In the case of DNA, an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention (see Lilly, 119 F.3d at 1566 (quoting Fiers, 984 F.2d 15 1171 ).
Therefore, neither art nor the specification provide sufficient support that the deposited strain of L. crispatus will not cause adverse effects on the skin.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
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 20, 26, 29, 38-39 and 42 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. Claims 20, 26, 29, 38-39 and 42 recite “biomechanical properties”. It is unclear as to what is meant by the phrase. Clarification/correction is required.
Claim 27 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 27 recite “part of the body”. It is unclear which part of the body. Clarification/correction is required.
Claims 26, 31 and 32 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. Claims 26, 31 and 32 recite “characterized in”. It is unclear as to what the phrase is referring to. Clarification/correction is required.
Claim 42 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 42 recite “identifying on an individual of an area of healthy skin”. It is unclear as to what the phrase is referring to. Clarification/correction is required.
Claims 17-23, 25-32, 38-39 and 42 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. The claims are drawn to a cosmetic or nutraceutical method however, the claims recite method steps. Therefore, the product and method steps are recited in the same claim. MPEP 2173.05 states “a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to "[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data" was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited "an input means" and required a user to use the input means was found to be indefinite because it was unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means."); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
In contrast, when a claim recites a product and additional limitations which focus on the capabilities of the system, not the specific actions or functions performed by the user, the claim may be definite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See Mastermine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 124 USPQ2d 1618 (Fed. Cir. 2017)”. Clarification/correction is required.
Status of Claims
No claims allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vanessa L Ford whose telephone number is (571)272-0857. The examiner can normally be reached Monday to Friday 9:00 -5:30 EST.
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/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
