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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments and declaration filed 3/30/26 are acknowledged. Any objection or rejection from the 10/29/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, SEQ ID NO:2 was elected. SEQ ID NO:2 includes Ala at residue 168 while the corresponding residue in SEQ ID NO: 3 (residue 5) is Asn. Claim 1 no longer recites SEQ ID NO:2. The search was extended to the extent necessary to determine patentability.
Claims 2-5, 8, 10-11 and 14 have been canceled.
Claims 1, 6-7, 9, 12-13 and 15-16 are being examined.
Priority
The priority information is provided in the filing receipt dated 4/11/23.
Claim Objections
This objection is a new objection necessitated by amendment.
Claim 7 is objected to because of the following informalities:
Claim 7 as amended recites ‘wherein the polypeptide consisting essentially of’. Claim 6 recites ‘wherein the polypeptide consists essentially of’. For consistency, claim 7 should recite ‘wherein the polypeptide consists essentially of’.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claims were previously rejected under 103 based on the references cited below. Since the claims have been amended the rejection is updated to correspond to the instant claims.
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.
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.
Claim(s) 1, 6-7, 9, 12-13 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morino et al. (as cited with IDS 7/3/24; ‘Morino’) in view of Berg et al. (US 2011/0207670; ‘Berg’) in view of Wu et al. (US 2015/0031620; ‘Wu’).
Morino teach a patient who was treated with a therapy including recombinant human soluble thrombomodulin (abstract). Morino specifically teach the patient was male (page 3079 last paragraph) who had alopecia (figure 1) and blisters on the skin (figure 4). Morino teach that colonoscopy and espophagogastroduodenoscopy were performed (page 3080 2nd column and figure 2). Morino teach that the treatment was successful (abstract and page 3079 first complete paragraph of column 2).
Morino does not teach administration to the skin as in claim 1.
Berg teach that human thrombomodulin is SEQ ID NO:1 (section 0026 and sequence listing). Berg teach that soluble thrombomodulin lacks the transmembrane and cytoplasmic domains (section 0026). Berg teach that soluble thrombomodulin is SEQ ID NO:4 (section 0026 and sequence listing). In relation to SEQ ID NO:1, SEQ ID NO:4 includes removal of the signal peptide (first 19 residues) and residues 515-575 (corresponding to the transmembrane and cytoplasmic domain (sections 0026 and sequence listing)). Berg recognizes the use of DNA to make the polypeptide (section 0033). Berg recognizes carriers in the composition (section 0044). Berg teach that the dosage depends on numerous factors and can be optimized using standard techniques (section 0043).
Wu teach pharmaceutical compositions comprising a thrombomodulin for promoting wound healing (abstract). Wu specifically teach that wounds include blisters (section 0039 and claim 11). Wu teach that the administration can be topical (sections 0015, 0037, 0057 and 0059). Wu teach that the composition can be a cream, spray or solution (section 0036). Wu teach fragments coding for TMD23 (section 0052) and specifically recites SEQ ID NO:1 which corresponds to 274 residues in length. Wu teach the use of an effective amount (claim 1). Wu recognizes that DNA can be used to make the protein of interest (sections 0052-0053). Wu expressly teach that subjects were shaved (section 0057).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Morino because Morino specifically teach treating with a therapy including recombinant human soluble thrombomodulin (abstract). Thus one would have been motivated to use such protein as was taught in the prior art (see SEQ ID NO:4 of Berg). Morino expressly recognizes a patient who had blisters on the skin (figure 4). Wu teach pharmaceutical compositions comprising a thrombomodulin for promoting wound healing (abstract). Wu specifically teach that wounds include blisters (section 0039 and claim 11). Since Wu teach that the administration can be topical (sections 0015, 0037, 0057 and 0059) and teach that the composition can be a cream, spray or solution (section 0036) one would have been motivated to prepare and administer in such fashion. Since Wu expressly teach that subjects were shaved (section 0057) one would have been motivated to do such in order to access the skin for the treatment. With respect to the polypeptide, Berg teach that human thrombomodulin is SEQ ID NO:1 (section 0026 and sequence listing). Berg teach that soluble thrombomodulin lacks the transmembrane and cytoplasmic domains (section 0026). Berg teach that soluble thrombomodulin is SEQ ID NO:4 (section 0026 and sequence listing). Further, since
Wu teach fragments coding for TMD23 (section 0052) and specifically recites SEQ ID NO:1 which corresponds to 274 residues in length one would have been motivated to make and use the peptide of Berg. One would have had a reasonable expectation of success since Morino teach a patient who was treated successfully with a therapy including recombinant human soluble thrombomodulin (abstract).
In relation to the subject of claim 1, Morino specifically teach the patient was male (page 3079 last paragraph) who had alopecia and figure 1 shows male pattern hair loss (figure 1).
In relation to the polypeptide of claims 1 and 6-7, Morino teach a patient who was treated with a therapy including recombinant human soluble thrombomodulin (abstract). Morino teach human soluble thrombomodulin (abstract) but does not recite the sequence of human soluble thrombomodulin. Berg teach that human thrombomodulin is SEQ ID NO:1 (section 0026 and sequence listing). Berg teach that soluble thrombomodulin lacks the transmembrane and cytoplasmic domains (section 0026). Berg teach that soluble thrombomodulin is SEQ ID NO:4 (section 0026 and sequence listing). In relation to SEQ ID NO:1, SEQ ID NO:4 includes removal of the signal peptide (first 19 residues) and residues 515-575 (corresponding to the transmembrane and cytoplasmic domain (sections 0026 and sequence listing).
MPEP 2111.03 III states that absent a clear indication in the specification or claims, ‘consisting essentially of’ will be construed equivalent to comprising. In the instant case, the specification does not provide a clear indication so ‘consisting essentially of’ will be construed equivalent to comprising and claims 1 and 6-7 are interpreted in such fashion. Residues 387-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:3. Residues 408-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:4.
In relation to the composition of claims 1 and 15-16, Morino teach a patient who was treated with a therapy including recombinant human soluble thrombomodulin (abstract) where such treatment would involve a composition. Berg recognizes carriers in the composition (section 0044). Wu teach that the composition can be a cream, spray or solution (section 0036).
In relation to the intended use ‘for facilitating hair growth or regrowth’ and ‘to increase’ and effective amounts, Morino specifically teach the patient was male (page 3079 last paragraph) who had alopecia (figure 1) and figure 1 shows male pattern hair loss (figure 1). Since Morino teach an agent as claimed such agent is interpreted as being effective. Berg teach that the dosage depends on numerous factors and can be optimized using standard techniques (section 0043). Since the prior art suggest steps as claimed the claim limitations are met.
In relation to the applying physical intervention of claim 1 and 13, Wu expressly teach that subjects were shaved (section 0057) so one would have been motivated to do such in order to access the skin for the treatment. A shaving device meets the limitation of ‘microsurgical device’ because there is nothing to preclude shaving as a step of microsurgery. In relation to claim 13, Wu teach that the administered agent showed a wound healing effect (section 0059) so one would have been motivated to repeat administration of the active agent (a chemical intervention).
In relation to claim 9, Berg recognizes the use of DNA to make the polypeptide (section 0033). Wu recognizes that DNA can be used to make the protein of interest (sections 0052-0053).
In relation to claim 12, Wu teach that the administration can be topical (sections 0015, 0037, 0057 and 0059). Wu teach that the composition can be a cream, spray or solution (section 0036).
Response to Arguments - 103
Applicant's arguments and declaration filed 3/30/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
In response to applicant's argument that Wu is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Wu (and all of the references used in the 103 rejection) teach known properties and functionalities of thrombomodulin. Thus, the references are from the same field of endeavor (see MPEP 2141.01(a)). MPEP 2141.01(a) states: “The Federal Circuit reads KSR as "direct[ing] us to construe the scope of analogous art broadly" because "familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle." Wyers v. Master Lock Co., 616 F.3d 1231, 1238, 95 USPQ2d 1525, 1530 (Fed. Cir. 2010) (quoting KSR, 550 U.S. at 402, 127 S. Ct. at 1727)”.” The instant claims relate to uses of a familiar protein (thrombomodulin).
Although applicants argue about the purpose of the physical intervention, MPEP 2144 IV recognizes that the reason to modify a reference can be different from the applicants. As claimed, the physical intervention step encompasses ‘applying physical intervention’. Since the prior art suggest such step the claim limitation is met. MPEP 2111.02 II recognizes that statements related to a purpose or intended use should be evaluated to determine if there is a manipulative difference. In the instant case, the intention to ‘increase skin penetration’ does not require a manipulative difference in the context of a shaving device. Shaving necessarily removes hair which makes the skin accessible thus allowing for skin penetration. Further, the claims broadly recite ‘administering a composition to the skin of the subject’.
Although applicants argue about creating micro-channels, such recitation does not appear in the instant claims.
Although applicants argue about a teaching away, MPEP 2123 II recognizes that a teaching away criticizes, discredits or otherwise discourages the solution claimed. It has not been established how the references criticize, discredit or otherwise discourage the solution claimed
Although applicants argue about the references individually specifically with respect to the administration mode, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants refer via a declaration to filing more than 30 patents (section 2), a patent application is separate and distinct from a granted patent.
Although applicants argue via the declaration about the length of the peptides, MPEP 2111.03 III states that absent a clear indication in the specification or claims, ‘consisting essentially of’ will be construed equivalent to comprising. In the instant case, the specification does not provide a clear indication so ‘consisting essentially of’ will be construed equivalent to comprising and claims 1 and 6-7 are interpreted in such fashion. Residues 387-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:3. Residues 408-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:4. The active steps of claim 1 include applying and administering which are suggested by the prior art. The claims are not drawn to methods of identifying domains.
Although applicants via the declaration about SEQ ID NO:3 and SEQ ID NO:4 and a ‘superior effect’, it is unclear what the superior effect is in relation to. The data as shown in the declaration appears to only relate to SEQ ID NOs: 3 and 4. MPEP 716.02(a) II recognizes superiority but in the context of comparison to a prior art compound. MPEP 716.02(e) expressly refers to a comparison to the prior art. The declaration does not appear to include any comparison to any prior art.
Although applicants via the declaration about truncated polypeptides, MPEP 2111.03 III states that absent a clear indication in the specification or claims, ‘consisting essentially of’ will be construed equivalent to comprising. In the instant case, the specification does not provide a clear indication so ‘consisting essentially of’ will be construed equivalent to comprising and claims 1 and 6-7 are interpreted in such fashion. Residues 387-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:3. Residues 408-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:4. The active steps of claim 1 include applying and administering which are suggested by the prior art. The claims are not drawn to truncated peptides.
Although applicants argue via the declaration about identification of a discrete, minimal functional core, the active steps of claim 1 include applying and administering which are suggested by the prior art. MPEP 2111.03 III states that absent a clear indication in the specification or claims, ‘consisting essentially of’ will be construed equivalent to comprising. In the instant case, the specification does not provide a clear indication so ‘consisting essentially of’ will be construed equivalent to comprising and claims 1 and 6-7 are interpreted in such fashion. Residues 387-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:3. Residues 408-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:4.
Although applicants argue via the declaration about peptide size and discovery of an active site, the claims are not drawn to discovering an active site. With respect to the peptide length, MPEP 2111.03 III states that absent a clear indication in the specification or claims, ‘consisting essentially of’ will be construed equivalent to comprising. In the instant case, the specification does not provide a clear indication so ‘consisting essentially of’ will be construed equivalent to comprising and claims 1 and 6-7 are interpreted in such fashion. Residues 387-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:3. Residues 408-426 of SEQ ID NO:4 of Berg correspond to instant SEQ ID NO:4.
The declaration under 37 CFR 1.132 filed 3/30/26 is insufficient to overcome the rejection of claims under 103 as set forth above because: MPEP 716.02(b) recognizes that the burden is on the applicant to establish that results are unexpected and significant. MPEP 716.02(a) II recognizes superiority but in the context of comparison to a prior art compound. MPEP 716.02(e) expressly refers to a comparison to the prior art. The declaration does not appear to include any comparison to any prior art. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. There are inadequate facts to conclude any unexpected results or any unexpected results commensurate in scope with the claims.
Conclusion
Applicant's amendment necessitated any 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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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