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
This office action is a response to applicant’s communication submitted July 15, 2026, wherein claims 1, 3, and 7-10 are amended, claim 2 is canceled, and new claims 11 and 12 are introduced. This application is a national stage application of PCT/JP2022/026679, filed July 5, 2022, which claims priority to foreign application JP2021-111683, filed July 5, 2021.
Claims 1 and 3-12 are pending in this application.
Claims 1 and 3-12 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted July 15, 2026, with respect to the rejection of claims 1-6, 9, and 10 under 35 USC 102(a)(1) for being anticipated by Qun Yu et al., has been fully considered and found to be persuasive to remove the rejection as independent claim 1 has been amended to require that the composition be an aqueous solution and claims 7-10 have been amended to require that the alginate is sulfated. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted July 15, 2026, with respect to the rejection of claims 1, 3, and 5-9 under 35 USC 102(a)(1) for being anticipated by Cohen et al., has been fully considered and found to be persuasive to remove the rejection as independent claim 1 has been amended to require administering the composition not a specific location. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted July 15, 2026, with respect to the rejection of claim 3 under 35 USC 103 for being obvious over Qun Yu et al. in view of Basta et al., has been fully considered and found to be persuasive to remove the rejection as independent claim 1 has been amended to require that the composition be an aqueous solution. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted July 15, 2026, with respect to the rejection of claim 3 under 35 USC 103 for being obvious over Cohen et al. in view of Basta et al., has been fully considered and found to be persuasive to remove the rejection as independent claims 1 and 9 have been amended to require administering the composition not a specific location. Therefore the rejection is withdrawn.
Applicant’s amendment necessitates the following new grounds of rejection:
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 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al. (US pre-grant publication 2011/0229432, cited in PTO-892)
Independent claim 1 claims a method of administering an aqueous solution of alginic acid to a patient in need of tissue formation. Dependent claim 6 requires that the aqueous solution is crosslinked with calcium or polylysine.
Choi et al. discloses a thermosensitive comprising an aqueous solution having an appropriate viscosity and a drug selectively inhibiting inflammatory response, which can be applied to a wound on a human body. (p. 1 paragraph 10) Applying the composition to a wound would necessarily involve administering it to one of the recited tissues, in a subject in need of tissue formation. The polymer used in the aqueous solution can include various biological polymers including alginic acid. (p. 2 paragraph 33) Additionally the crosslinking agent can include any of a number of crosslinking agents including calcium or polylysine. (p. 2 paragraph 34)
Therefore Choi et al. anticipates the present claims.
Claim 1 id rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lifshitz et al. (PCT international publication WO2008/111074, Reference included with PTO-892)
Independent claim 1 claims a method of administering an aqueous solution of alginic acid to a patient in need of tissue formation. Lifshitz et al. discloses novel pharmaceutical compositions for promoting repair of damaged muscle tissue such as infarcted myocardial tissue, comprising administering to the tissue an aqueous solution of a polymer that is capable of self-gelling following deposition around the tissue. (p. 2 lines 19-23, p. 4 lines 26-30) While muscle itself is not epithelium, the heart contains epithelial tissue (e.g. lining blood vessels or endocardium) and is also located deeper in the body than epithelial tissue. In a specific embodiment the polymer is sodium alginate. (p. 3 lines 18-23) Therefore administering this solution to the myocardium would necessarily anticipate present claim 1.
Claims 7, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babavalian et al. (Reference included with PTO-892)
Independent claim 7 claims a method comprising administering a composition containing sulfated alginic acid to a patient in need of tissue formation, wherein the tissue is an epithelial tissue a tissue lining an epithelial tissue, or a tissue deeper than an epithelial tissue. Independent claim 9 similarly claims an identical method wherein the subject is in need of tissue regeneration, and independent claim 10 identifies the subject as in need of wound healing.
Babavalian et al. discloses hydrogels of sulfated alginic acid. (p. 392 left column second and third paragraphs) These hydrogels were then administered to wound sites on experimental animals, either with or without recombinant platelet-derived growth factor. (p. 392 right column second and third paragraphs) Sulfated alginate promoted wound healing (and therefore tissue formation/regeneration) with or without added growth factor. (p. 393 right column last paragraph – p. 394 right column second paragraph)
Therefore Babavalian et al. anticipates the present claims.
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, 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.
Claims 1, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US pre-grant publication 2011/0229432, cited in PTO-892)
The disclosure of Choi et al. is discussed above. While as discussed previously Choi et al. anticipates present claims 1 and 6, even assuming for the sake of argument that the disclosure of Choi is not seen to literally recite a method of treating a wound according to the present claims, or the specific combination of the polymer alginic acid with calcium or polylysine, it would have been obvious to one of ordinary skill in the art at the time of the invention to select these particular components from among the lists described as usable by Choi, on the basis of these ingredients having been suggested by the reference. Furthermore it would have been obvious to one of ordinary skill in the art to apply the solution to a wound in a patient in need of tissue formation (healing) based on the description of this use as the intended purpose of the disclosed compositions.
Furthermore regarding the viscosity described in claim 4, Choi et al. describes the viscosity of the composition as a result-effective variable. (see the reference to “proper viscosity” in paragraphs 10 and 11) Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to determine the appropriate value for the viscosity of the aqueous solution, rendering the broad range in present claim 4 obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. as applied to claims 1, 4, and 6 above, and further in view of Basta et al. US pre-grant publication 2014/0275519, of record in previous action)
The disclosure of Choi et al. is discussed above. Choi does not describe the endotoxin level of the alginate used in the aqueous solution. However, Basta et al. discloses that alginate has a high level of endotoxin (30000-60000 EU/g) which must be reduced for pharmaceutical use. (p. 1 paragraphs 4-5) Basta et al. further discloses a method of reducing the endotoxin content to below 20EU/g, or 0.02 EU/mg. (p. 1 paragraphs 11-12) It would have been obvious to one of ordinary skill in the art at the time of the invention to use a low-endotoxin alginate such as that described by Basta et al. in the compositions described by Choi et al. One of ordinary skill in the art would have seen the disclosure of Basta et al. as suggesting the use of a low endotoxin alginate as appropriate for medical purposes such as wound healing or prevention of adhesions.
Therefore the invention taken as a whole is prima facie obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lifshitz et al. (PCT international publication WO2008/111074, Reference included with PTO-892)
The disclosure of Lifshitz et al. is discussed above. Furthermore regarding present claim 5, Lifshitz et al. discloses a preferred monomer ratio for the alginate between 1:1 and 3:1 G/M, which corresponds to a range of 0.33-1.0 M/G. It would have been obvious to one of ordinary skill in the art at the time of the invention to use a solution having a M/G ratio of 0.33-0.999 in the method described by Lifshitz, in view of the fact that the disclosed range overlaps to an extreme degree with the claimed range, and almost all embodiments falling within the disclosed range would infringe the claimed range.
Therefore the invention taken as a whole is prima facie obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lifshitz et al. as applied to claims 1 and 5 above, and further in view of Basta et al. US pre-grant publication 2014/0275519, of record in previous action)
The disclosure of Lifshitz et al. is discussed above. Lifshitz does not describe the endotoxin level of the alginate used in the aqueous solution. However, Basta et al. discloses that alginate has a high level of endotoxin (30000-60000 EU/g) which must be reduced for pharmaceutical use. (p. 1 paragraphs 4-5) Basta et al. further discloses a method of reducing the endotoxin content to below 20EU/g, or 0.02 EU/mg. (p. 1 paragraphs 11-12) It would have been obvious to one of ordinary skill in the art at the time of the invention to use a low-endotoxin alginate such as that described by Basta et al. in the compositions described by Lifshitz et al. One of ordinary skill in the art would have seen the disclosure of Basta et al. as suggesting the use of a low endotoxin alginate as appropriate for medical purposes such as injecting into ischemic myocardial tissue.
Therefore the invention taken as a whole is prima facie obvious.
Claims 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Babavalian et al. as applied to claims 7, 9, and 10 above, and further in view of CN104926889A to Guangxi University. (Reference and English machine translation included with PTO-892, herein referred to as Guangxi)
The disclosure of Babavalian et al. is discussed above. Babavalian et al. does not disclose embodiments wherein the sulfated alginate composition contains an additional sulfated compound. However, Guangxi discloses that sucrose sulfate compounds are antibacterial agents useful for treating infections in wounds. (p. 4 paragraph 5 – p. 5 paragraph 11) It would therefore have been obvious to one of ordinary skill in the art to include the sucrose sulfate compounds in the wound healing alginate sulfate compositions described by Babavalian et al. One of ordinary skill in the art would have found this to be obvious based on the expectation that including these compositions would help to treat or prevent infection of the wound being treated.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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, Scarlett Y Goon can be reached at 571-270-5241. 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.
/ANDREA OLSON/ Primary Examiner, Art Unit 1693 9/4/2026
Prosecution Insights