DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CONTINUING DATA
This application is a 371 of PCT/EP2023/051998 01/27/2023
FOREIGN APPLICATIONS
EP 22153591.7 01/27/2022
Claims 1-15 are pending.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
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.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims. The claims recite a “use” but do not recite any steps. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. MPEP 2173.05(q).
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a use of oligosaccharides which include natural products such as LNT and LNnT, and are contained within a natural product, human milk. This judicial exception is not integrated into a practical application because no method steps are claimed. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not require additional elements. The claims are “use” claims which do not recite any additional elements and are directed to natural products.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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 1-15 are “use” claims which do not recite any steps. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 2 recites the broad recitation “tri-, tetra-, hexa-, octa- or decasaccharides,” and the claim also recites preferably the group of tri-, tetra and hexasaccharides, and most preferably tetrasaccaharides, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 recites a broad group of oligosaccharides followed by preferably certain oligosaccharides, followed by most preferably certain oligosaccharides.
Claim 7 recites a broad concentration limitation followed by preferably a narrower range and most preferably a narrower range.
Claim 9 recites a broad concentration limitation followed by preferably a narrower limitation and most preferably a narrower limitation.
Claim 11 recites a broad subject followed by preferably a certain age group, and most preferably a certain age group.
Claim 12 recites a broad group of oligosaccharides followed by preferably certain oligosaccharides, followed by most preferably certain oligosaccharides.
Claim 13 recites a broad concentration limitation followed by preferably a narrower range and most preferably a narrower range.
Claim 14 recites a broad amount followed by preferably a narrower amount and most preferably a narrower amount.
Regarding claims 9 and 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 recites a carrier “consisting of” at least 30 wt.% of water. The claim is unclear because “consisting of” is closed language, meaning that the carrier must be water and water only. If the carrier consists of water, there cannot be another element present, so “at least 30 wt.%” does not make sense.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zula (I Tried Forming A Skincare Regime With Breast Milk To See If It Actually Makes Me Look Younger, internet article dated December 6, 2019, https://zula.sg/breast-milk-skincare/).
Zula teaches a method wherein breast milk was applied to the face and left on the skin for a few minutes. Page 4. The method was intended for anti-aging. Page 1. Zula teaches that she did feel that she looked younger after application of breast milk moisturizer. Page 6.
Human milk inherently contains LNT and LNnT. Kenney (Front. Pediatr. 13:1649609, 2025) teaches that human milk contains at least 0.50 g/L LNT and 0.12 g/L LNnT or more, depending on the age of the infant. The total converts to a minimum of 0.062% of LNT and LNnT combined, or 0.05% of LNT alone, or 0.012% of LNnT alone. See Table 2. Thus, the limitations of claims 7 and 13 are inherent.
Liang (J. Agric. Food Chem. 2018, 66, 9761-9769) teaches that human milk is a natural emulsion containing triacylglycerol droplets. See abstract. Kim (Clinical and Experimental Pediatrics 2020;63(8):301-309) teaches that human breast milk contains 87-88% water. See abstract. Thus, the limitations of claims 9-10 are inherent.
The wherein clause in claim 5 is inherent because a compound and its properties are inseparable.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zula in view of Baumann (How Much Skin Cream Should I Use on My Face? Internet article dated January 3, 2020, https://www.lesliebaumannmd.com/how-much-skin-cream-should-i-use-on-my-face).
Zula teaches as set forth above but does not teach how much of the composition was applied in mg/cm2.
Baumann teaches that 2 mg/cm2 is a standard amount of cream to put on the face. Page 4.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to apply around 2 mg/cm2 of Zula’s composition to the face for anti-aging because 2 mg/cm2 is a standard amount to apply for facial creams. The skilled artisan would have optimized the amount beginning from this standard to achieve the appropriate amount of coverage.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 17-22 of copending Application No. 19122080 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a composition for application to the skin which contains 0.2-5 wt% of a human milk oligosaccharide such as LNT orLNnT. See claims 1-5. The composition contains a carrier consisting of at least 30 wt% of water (claim 9). The composition is an O/W emulsion (claim 11). The reference composition is intended for use as a sunscreen (which the skilled artisan would understand is a leave-on composition) and the current composition is intended for anti-aging, but the anti-aging effect is inherent in applying the same compound at the same concentration to the skin. The reference claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 16-20 of copending Application No. 19121564 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a composition for application to the skin which contains 0.2-5 wt% of a human milk oligosaccharide such as LNT or LNnT. See claims 1-4. The composition contains at a carrier consisting of at least 30 wt% of water (claim 9). The composition is an O/W emulsion (claim 10). The reference composition is intended for use as a sunscreen (which the skilled artisan would understand is a leave-on composition) and the current composition is intended for anti-aging, but the anti-aging effect is inherent in applying the same compound at the same concentration to the skin. The reference claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14, and 16-22 of copending Application No. 19122091 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a composition for application to the skin which contains at least 0.2 wt% of a human milk oligosaccharide such as LNT orLNnT. See claims 1-7. The composition contains at a carrier consisting of at least 30 wt% of water (claim 10). The composition is an O/W emulsion (claim 12). The reference composition is intended for use as a sunscreen (which the skilled artisan would understand is a leave-on composition) and the current composition is intended for anti-aging, but the anti-aging effect is inherent in applying the same compound at the same concentration to the skin. The reference claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-30 of copending Application No. 18685028 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method comprising administering 0.01-10 wt.% LNT to the skin (claims 13-15). The composition comprises at least 40% water (claims 17-18). The composition is a leave-on composition (claim 19). The reference composition is intended for use as an acne treatment and the current composition is intended for anti-aging, but the anti-aging effect is inherent in applying the same compound at the same concentration to the skin. The reference claims anticipate the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 17-22 of copending Application No. 19122080; or claims 1-11 and 16-20 of copending Application No. 19121564; or claims 1-12, 14, and 16-22 of copending Application No. 19122091; or claims 13-30 of copending Application No. 18685028 in view of Baumann (How Much Skin Cream Should I Use on My Face? Internet article dated January 3, 2020, https://www.lesliebaumannmd.com/how-much-skin-cream-should-i-use-on-my-face).
The reference applications claim as set forth above, but do not claim the amount of composition to be administered in mg/cm2.
Baumann teaches that 2 mg/cm2 is a standard amount of cream to put on the face. Page 4.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to apply around 2 mg/cm2 of the reference applications’ compositions to the face for anti-aging because 2 mg/cm2 is a standard amount to apply for facial creams. The skilled artisan would have optimized the amount beginning from this standard to achieve the appropriate amount of coverage.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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