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 . The submission filed on 06/04/2024 has been entered. Claims 1-20 are pending in this application and are currently under examination.
Priority
This is US Application No. 18/732,718 filed on 06/04/2024.
Information Disclosure Statement
The information disclosure statement (IDS) with appropriate assertion under 37 CFR 1.98 filed on 03/18/2025, 07/16/2025, and 09/24/2025 have been considered.
Claim Objections
Claims 2-5 are objected to because of the following informalities: In claims 2 and 3, change the incorrect recitation “the use as a promotor of tissue re-epithelialization comprises the administration”(lines 2 to 3) to “the composition is for administration” to avoid redundancy and to tie with the preceding composition. In claims 4 and 5, delete the excessive recitation “use as a promotor of” because the use cannot “comprises an increase in epithelial cell viability”. Appropriate correction is required.
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 5, 7, 8, 10, 14, 17, and 20 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.
Regarding claims 5, 7, 8, 10, and 14, the phrase “in particular” or "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “higher” in claim 12 is a relative term which renders the claim indefinite. The term “higher” is not 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 invention.
Claims 17 and 20 recite “A use of a combination of sugars”, but fails to recite steps. “It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections”. See MPEP 2173.05(q). To advance the prosecution, claims 17 and 20 are interpreted as a composition claim.
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.
(I) Claims 1-15, 17, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1-15, 17, and 20 recite a composition (or a dressing, bandage or plaster; or a liquid or semi-solid composition) comprising galactose and fucose, which are products of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that mixing them in the recited application or ratio (i.e., for use as a promotor of tissue re-epithelialization; or for administration; or for use in treating lesions in an individual; or galactose to fucose is in the range of 1:9 to 9:1) changes the structure, function, or other properties of the galactose and fucose in any marked way. Instead, the galactose or fucose retains its naturally occurring structure and properties (e.g., skin moisturizing properties). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, mixing of galactose and fucose was well-understood, routine and conventional in the field, as evidenced by the reference under the 102/103 rejection below. The recitation of specific use or molar ratio of galactose and fucose does not affect this analysis, because it was also well-understood, routine and conventional at the time to mix specific molar ratio of galactose to fucose, e.g., to achieve commercially acceptable chemical complex for different purposes. Thus, the mixing of different molar ratio of galactose to fucose, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
(II) Claims 17 and 20 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 "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. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). See MPEP 2173.05(q).
Claim Rejections - 35 USC § 102/103
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.
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.
The factual inquiries 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lee et al. (KR20170111280, 2017-10-12, English machine translation is provided for citation here), hereinafter referred to a Lee ‘280).
With regard to structural limitations “a composition (or as a powder, as a patch, as an ointment dressing; or a dressing, bandage or plaster; or a liquid or semi-solid composition) comprising galactose and fucose in monosaccharide form (or relative concentration of galactose to fucose is in the range of 1:9 to 9:1)” (claims 1-15, 17, and 20), and “a method comprising administering to a patient in need thereof a therapeutically effective amount of a combination of sugars selected from the group consisting of galactose and fucose” (claims 16 and 19), and “a process for preparing a pharmaceutical composition, comprising: Combining a therapeutically effective amount of galactose and fucose and optionally of a pharmaceutically acceptable carrier” (claim 18):
Lee ‘280 disclosed a composition for moisturizing a skin, which comprises two or more kinds selected from the group consisting of a Japanese apricot extract, a white patterned thistle extract, a European equine extract, glucose, galactose, fucose and N-acetylglucosamine, and capable of increasing the moisture of the skin through one application to normal skin and diseased skin. Formulation (1) a mixture of glucose, galactose, fucose and N-acetylglucosamine. The formulation is selected from the group consisting of a softening agent, a nutritional lotion, a massage cream, a nutritional cream, a pack, a lotion, an ointment, a gel, a cream, a patch and a spray. The mixture of glucose, galactose, fucose and N-acetylglucosamine is mixed at a weight ratio of 1:0.5-2: 0.5-2: 0.5-2. Said disease is selected from the group consisting of dry skin, eczema, psoriasis, atopic dermatitis, jaundice and pemphigus. Said pharmaceutical composition is in the form of a parenteral dosage unit selected from the group consisting of solid, semi-solid and liquid (page 2/12, Abstract; para. “Claims (15); page 3/12, para. 1).
Thus, these teachings of Lee ‘280 anticipate Applicant’s claims 1-20 and the composition or application would also carry the same properties or would also achieve the intended results, including “for use as a promotor of tissue re-epithelialization”, “for administration”, “an increase in epithelial cell viability”, “increases the cell viability above 105% the latest after 72 hours”, “galactose is D-galactose and fucose is L-fucose”, “the tissue is fibroblast-free epithelial tissue”, “applied topically”, “a stimulation of cell proliferation via an activation of a Pl3K/AKT/mTOR pathway”, “a stimulation of cell proliferation via a higher access to fucose monosaccharide molecules as an essential building block”, “can be directly applied to a lesion”, “for use in treating lesions in an individual”, and/or “in the manufacture of a medicament”, required by claims 1-20. Or, in an alternative, skilled artisan would follow the teachings of Lee ‘280 to select only two sugars from glucose, galactose, fucose and N-acetylglucosamine to prepare a composition for skin application.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 13, 18, and 20 of copending Application No. 19/472,244 (APPLICANTS: PathoBlock Therapeutics GmbH & Co. KG, Berlin, GERMANY, the claim set of 2025-10-03). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl ‘244 claims “A composition (or A dressing, bandage or plaster) comprising D-galactose and L-fucose for use in treating or preventing infections in an individual, wherein the composition is administered to the individual in solid form, preferably as a powder, or wherein the composition is administered to the individual in liquid form and wherein the liquid composition is produced by mixing D-galactose and L-fucose in solid form with a liquid no longer than 3 hours before administering the composition to the individual (or wherein the relative concentration of D-galactose to L-fucose is in the range of 1:10000 to 10000:1, preferably 1:1; or wherein the infection is a respiratory tract infection, for example in patients suffering from cystic fibrosis, ear nose throat infection, for example otitis externa, skin infection, dermatitis, wound infection, urinary tract infection, catheter-related infection, osteomyelitis, implant-associated infection, eye infection, surgical site infection or joint infection)” (claims 1, 3-5, 7, 13, and 18), and “A method of treating or preventing infections in an individual, the method comprising administering a composition according to claim 1 to an individual in need thereof” (claim 20), which read on claims 1-20 of this Application, and would also carry the same properties or would also achieve the intended results, including “for use as a promotor of tissue re-epithelialization”, “for administration”, “an increase in epithelial cell viability”, “increases the cell viability above 105% the latest after 72 hours”, “galactose is D-galactose and fucose is L-fucose”, “the tissue is fibroblast-free epithelial tissue”, “applied topically”, “a stimulation of cell proliferation via an activation of a Pl3K/AKT/mTOR pathway”, “a stimulation of cell proliferation via a higher access to fucose monosaccharide molecules as an essential building block”, “can be directly applied to a lesion”, “for use in treating lesions in an individual”, and/or “in the manufacture of a medicament”, required by claims 1-20. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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, Renee Claytor can be reached at 571-272-8394. 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.
/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
Prosecution Insights