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
Filing Receipt and Priority
The filing receipt mailed 03/07/2024 states that the instant application is a CON of PCT/US2021/082287, filed 12/04/2023, which claims benefit of provisional application 63/430,172, filed 12/05/2022.
The instant claims fid support in the provisional application. Therefore, the effective filing date is 12/05/2022.
Drawings
The drawings are objected to for the following:
Figures 7A-D and Figures 8A-D cannot be read as the text overlaps on itself.
Information Disclosure Statement
The information disclosure statement received 05/30/2024 has been considered.
Rejections
Claim Rejections - 35 USC § 112(b)
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.
Use of “/”
Claim 30 is 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.
Claim 30 states “..preserving the chemical structure and/or prevents hydrolysis/degradation of the compound of Formula (I).”
The use of the “/” is indefinite as it is not clear if the claim limitation means “prevention of hydrolysis or degradation”, “prevention of hydrolysis and degradation”, or the combination of “hydrolysis and/or degradation”.
Examiner suggests amending the claim to state one of the conjunctions above. The use of “and/or” is not indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an 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.
Claim(s) 1-2, 4-5, 11-14, 17, 30, 32, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu (Bioorganic & Medicinal Chemistry Letters, 22, 2012, supporting information included) as evidenced by Ni (Biochemical and Biophysical Research Communications, vol. 369, Iss. 2, 2008).
Zhu in its supporting information, p. S5, Figure S1 discloses the following compound 38 as a test compound used in a quorum sensing assay.
Compound 38
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Zhu on p. 6414, right col. paragraph 2 states “For initial studies, the MM32 strain of V. harveyi,…was chosen for anti-quorum sensing assay. The inhibition effect was measured by the amount of luminescence produced in V. harveyi. Among 42 hit compounds were evaluated by following published literature procedures…”.
Zhu points to Ni. Ni on p. 592, sec. Materials and methods details the procedure for the assay discussed in Zhu, shown below.
Ni procedure
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The critical portion regarding the Zhu compound is where Ni writes “To these solutions freshly synthesized DPD solution (pH 7) was added for a final concentration of 5 μM.” Ni further states in sec. Results and Discussion that the bioluminescence produced in the anti-quorum sensing assay was dependent on the concentration of DPD in DMSO. Ni specifically states “In order to search for the optimal experimental conditions, we first tested the concentration effect of added DPD on bioluminescence production. Concentration-dependent luminescence production was observed from Fig. 1 it can be seen that maximal luminescence was observed within a wide concentration range of about 6-100 μM. These regions between 0-6 μM and between 100-400 μM were especially sensitive to concentration variations. Therefore, for our studies, we chose to use μM of DPD so as to satay in a ‘sensitive region.’ We also observed that DMSO, which was used to solubilize the boronic acids in making the stock solutions, has a significant effect on the bioluminescence production by V. harveyi. Therefore, one has to be very careful in controlling a consistent DMSO (or other organic solvent) concentration in preparing the final test solution.”
For the purpose of clarity, the structure of DPD is shown below.
DPD
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Instead of DPD, Zhu used 42 compounds purchased for in vitro testing. Of these 42 compounds, compound 38 was tested. Zhu states that they used the procedure outlined in Ni. Therefore, it is clear that Zhu made a solution of compound 38 in at least a concentration of 5 μM in DMSO solvent.
This embraces the limitations of claims 1-2, 4-5, and 11-14. Regarding claims 30, 32, and 36, which state one of the following “wherein the composition maintains chemical stability…” (claim 30), “wherein the composition is used for treating hair loss…” (claim 32), and “wherein the composition is applied to a scalp hair…”, these limitations are all considered an intended use which does not significantly alter the structure of the composition. As the structure of the composition in these claims is identical to that as in claim 1, they are also rejected under 102(a)(1).
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.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-5, 11-15, 17, 30, 32, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu (Bioorganic & Medicinal Chemistry Letters, 22, 2012, supporting information included) as evidenced by Ni (Biochemical and Biophysical Research Communications, vol. 369, Iss. 2, 2008) as applied to claims 1-2, 4-5, 11-14, 17, 30, 32, and 36 above.
Discussion of Zhu and Ni from the 102 rejection above is incorporated here. Neither Zhu or Ni discuss compositions comprising compounds wherein R1 is selected from -CH3, -(CH2)2CH3, and –(CH2)4CH3 or the compounds in claim 15, shown below.
Claim 15 Compounds
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These compounds differ from the Zhu compound 38 in that the R1 and R2 alkyl chains extend out via successive addition of a methyl group.
Compound 38, for comparison
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The compounds in claim 5 and claim 15 are homologues of compound 38. The MPEP states “Compounds which are... homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art to develop a composition comprising a compound from claim 5 or claim 15 via the teachings of Zhu and Ni. One of ordinary skill would be motivated to make a composition using the compounds as one of ordinary skill would expect similar properties for homologues of Zhu’s compound 38.
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.
U.S. Patent 12,251,459
Claims 1-5, 11-15, 17, 30, 32, and 36 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,251,459. Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims are drawn to a composition for treating hair loss of the following structure:
Reference claim 11 compound
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The reference claim 11 compound is embraces instant claim 1 and is homologous to instant claim 15 compounds (shown above).
U.S. Patent 12,527,794
Claims 1-5, 11-15, 17, 30, 32, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,527,794. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to a method for treating hair loss or hair thinning comprising administering a composition comprising a compound shown below:
Reference claim 1 compound
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The reference claim 11 compound is embraces instant claim 1 and is homologous to instant claim 15 compounds (shown above).
Allowable Subject Matter
Claims 7-10, 16, and 80 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624