DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 06/07/2024.
Election
2) Acknowledgment is made of Applicants’ election filed 07/06/26 in response to the restriction and the species election requirement mailed 05/06/26. Applicants have elected, without traverse, invention I and the Lactobacillus crispatus lysate active element species.
Status of Claims
3) Claims 4-11 and 13-22 have been amended via the preliminary amendment filed 06/07/2024.
Claims 1-22 are pending.
Claims 10-22 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 CFR 1.142(b) and M.P.E.P § 821.03.
Claims 1-9 are examined on the merits.
Information Disclosure Statement
4) Acknowledgment is made of Applicants’ Information Disclosure Statement filed 07/22/2024. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Drawings
5) Acknowledgment is made of Applicants’ drawings filed 06/07/24.
Priority
6) The instant AIA application, filed 06/07/2024, is the national stage 371 application of PCT/EP22/85164 filed 12/09/2022, which claims priority to application 10202113743T filed 12/10/2021 in Singapore. A certified copy of the foreign priority document is made of record.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
7) 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.
8) Claims 1-9 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 inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 1 is ambiguous and indefinite in the limitation ‘reducing …’. The term ‘reducing’ is a relative term which is not specifically defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claim. What precise level of reduction is encompassed, and reduction compared to what, is unclear.
(b) Analogous rejection applies to the amended dependent claim 8 with regard to the relative limitation “reduced”. See last line.
(c) The lack of a coordinating conjunction “and” or “or” between the limitations “Methyl POB” and “Propyl POB” in line 3 renders claim 3 ambiguous and indefinite. It is unclear whether or not the composition claimed in claim 3 comprises one of or all of the excipients recited therein. One of ordinary skill in the art cannot understand in an unambiguous way the scope of the claim.
(d) Analogous rejection applies to the dependent claim 4 with regard to the lack of a coordinating conjunction “and” or “or” between the limitations “agent,” and “biologically active peptide”. See last line.
(e) Claim 4 is ambiguous and indefinite in the abbreviated limitation “POB”. It is unclear what does this abbreviation represent or stand for. It is suggested that Applicants use the full terminology at first occurrence with the abbreviation retained within parentheses if the expansion is supported in the as-filed specification.
(f) Claims 2-9, which depend directly or indirectly from claim 1, are also rejected as being indefinite because of the indefiniteness identified above in the base claim.
Rejection(s) under 35 U.S.C § 101
9) 35 U.S.C § 101 states:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
10) Claims 1-8 are rejected under 35 U.S.C § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Instant claim 1 is directed to a composition comprising a lysate of Lactobacillus crispatus present in a generically recited effective amount. Per claim 2, said lysate comprises a physiologically acceptable carrier, for example, inert water. Per claim 3, said lysate comprises glycerol. Per claim 4, the composition comprises an antioxidant. The composition of claim 5 is in the form of milk. Lactobacillus crispatus is known in the art to occur naturally in the gut and vagina. See page 1 of the document entitled “Lactobacillus crispatus - Uses, Side effects, and More” by Chelsey McIntyre, pages 1-5, 2026. Probiotics get naturally broken down or lysed in the environment due to environmental pressures, fluctuations in temperature, pH, moisture and UV light. Because these elements are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of the instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). There is no indication within the as-filed application that the recited Lactobacillus crispatus source of the lysate is modified either genetically or in any other way compared to its naturally occurring counterpart Lactobacillus crispatus. A carrier, for example inert water, antioxidant, or milk, in the composition are also naturally occurring elements. Glycerol is also a naturally occurring molecule. See document entitled Glycerin, page 1, 2022. All of the effects of the lysate recited, for example, in claims 6-8, are the qualities or characteristics of the lysate in the composition and are the handiwork of nature. Thus, for at least one embodiment encompassed within the BRI, the claimed composition do not display markedly different characteristics compared to the naturally occurring elements or counterparts. Accordingly, each component of the composition is a ‘product of nature’ exception, and the claims are directed to judicial exceptions (Step 2A Prong One). Judicial exceptions include all natural products including those derived from natural sources such as naturally occurring microorganisms and other substances found in or derived therefrom, or from nature. The presence of naturally occurring judicial exceptions by themselves or with natural elements does not change it markedly significantly different and therefore does not make it subject matter eligible. Having a carrier, antioxidant, milk or glycerol with the recited lysate does not integrate the judicial exception(s) into a practical application (Step 2A Prong Two). There are no additional features in instant claims that would either integrate the judicial exceptions under Step 2A Prong 2, or add significantly more under Step 2B. The claims as a whole add nothing significant beyond the sum of their parts taken separately. Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. (June13, 2013).
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection would be the same under either status.
Rejection(s) under 35 U.S.C § 102
11) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12) Claims 1-9 are rejected under 35 U.S.C § 102(a)(1) and 102(a)(2) as being anticipated by US 20150093462 A1 as evidenced by 20040241128 A1 as evidenced by US 20040241128 A1.
US 20150093462 A1 disclosed a skin care lotion composition for topical application to skin comprising 1% by weight of a lysate of Lactobacillus crispatus and spring water, i.e., excipient or carrier. The lysate ferment was comprised in an amount from about 0.001 to about 10%. The prior art skin care composition further comprised surfactants, hyaluronic acid (i.e., an anti-wrinkle agent), glycerin, skin care serums, and/or a thickening agent. The prior art skin care composition is a lotion, which induced balanced skin renewal where the new cell generation or proliferation in the basal layer and the cellular differentiation in basal and epidermal layers is balanced, skin is most healthy, normalized and exhibits excellent integrity. The prior art composition further comprised a surfactant, a preservative, or a pH adjusting agent. See title; claims 6, 5 and 1; section [0020]; Example 1; and sections [0025], [0030], [0031], [0035], [0036], [0038], [0020], [0021] and [0010]. That the prior art glycerin is also known in the art as glycerol is inherent from the disclosure of US 20150093462 A1 in light of what is well known in the art. For example, see section [0013] of US 20040241128 A1. The composition of US 20150093462 A1 meets the structural requirements of instant claims and therefore is expected to necessarily have the same or the substantially same functions or effects in vitro, or in vivo such as improvement in skin health or improvement in the appearance of skin as recited in claim 1 or as recited in instant claims 6-8.
Claims 1-9 are anticipated by US 20150093462 A1. The reference of 20040241128 A1 is not used as a secondary reference in combination with the reference of US 20150093462 A1, but rather is used to show that every element of the claimed subject matter is disclosed by US 20150093462 A1 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ 1 (CCPA 1978).
13) Claims 1-9 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by CA 3101173 published 11/28/2019 (Applicants’ IDS) as evidenced by 20040241128 A1.
CA 3101173 disclosed a cosmetic composition, a cream, a lotion, an ointment, a gel, foam, a pharmaceutical composition, or a skin external preparation composition comprising an effective amount of lysates of Lactobacillus crispatus KBL693 which alleviates inflammatory symptoms, allergic diseases, skin conditions such as eczema, or atopic dermatitis. The prior art cosmetic composition is for topical or cutaneous application and it improves or treats cutaneous allergy, skin urticaria, atopic dermatitis, psoriasis, acne, eczema, or mycotic infection in a subject in need thereof. The prior art lysates of Lactobacillus crispatus KBL693 are comprised in an amount of 0.1% to 50% by weight based on the total weight of the composition. The prior art composition further comprised a binder, a filler, a stabilizer, a pharmaceutically acceptable carrier, an antimicrobial agent, glycerin, alcohol, See claims 1, 2, 7-13, 16-18, 15 and 14; page 21; section [74] on page 19; section [76] on pages 19-20; section [078] on pages 20-21; sections [108] to [114] and 118 on pages 26-27; lines 1-3 of page 28; sections [23] and [24] on pages 5-6; and pages 28-29. That the prior art glycerin is also known in the art as glycerol is inherent in light of what is well known in the art. For example, see section [0013] of US 20040241128 A1. The composition of CA 3101173 meets the structural requirements of instant claims and therefore is expected to necessarily have the same or the substantially same functions or effects in vivo such as improvement in skin health or improvement in the appearance of skin as recited in claim 1 or in vitro as recited in instant claims 6-8.
Claims 1-9 are anticipated by CA 3101173. The reference of 20040241128 A1 is not used as a secondary reference in combination with the reference of US 20150093462 A1, but rather is used to show that every element of the claimed subject matter is disclosed by CA 3101173 with the unrecited limitation(s) being inherent as evidenced by the state of the art. See In re Samour 197 USPQ 1 (CCPA 1978).
Objection(s) to Specification & Claim(s)
14) The specification and claims 1, 4, 7 and 8 are objected to for the following reason(s):
(a) The instant specification incorporates subject matter into the patent application by reference to a hyperlink “https”. For example, see page 21. However, attempts to incorporate subject matter into the patent application by reference to an active hyperlink and/or other forms of browser-executable code are considered to be improper incorporation by reference. See MPEP 608.01. Such embedded active hyperlinks and/or other forms of browser-executable code therefore require deletion or replacement with the phrase --hypertext transfer protocol secure-- as appropriate. MPEP § 608.01. It is suggested that Applicants examine the whole specification for similar recitations and make necessary correction.
(b) All non-italicized recitations of names of the various bacterial species and genera such as Lactobacillus, L. crispatus, candida, chlamydia and so on, throughout the specification are objected to. To be consistent with the practice in the art of scientific nomenclature of bacterial genus and species and of microorganisms, all such recitations should be italicized via deletion of the non-italicized limitations via strikethrough, for example, L. crispatus, and replacing with underlined italicized limitation, for example, L. crispatus.
(c) Claim 1 is objected to for the non-italicized recitation of “Lactobacillus crispatus”. To be consistent with the practice in the art of scientific nomenclature of bacterial genus and species, said limitation should be italicized via deletion of the non-italicized limitation via strikethrough, for example, Lactobacillus crispatus, and replacing it with underlined italicized limitation, for example, Lactobacillus crispatus.
(d) Claims 7 and 8 are objected to for lacking a preceding article prior to the limitation “amount” in line 2 of the claims. To be consistent with the correct format used in line 2 of claim 6, it is suggested that Applicants insert the limitation –an-- prior to the limitation “amount”.
(e) Claim 4 is objected to for lacking a coordinating conjunction “and” or “or” between the limitations “agent,” and “biologically active peptide”. See last line.
Conclusion
15) No claims are allowed.
Correspondence
16) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
17) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
September, 2026
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