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 .
Claims 1-10 are pending in the application. Preliminary amendment filed 22 March 2023.
Priority
This application is a 371 of PCT/CN2022/139994 filed 12/19/2022. This application claims foreign priority to CHINA CN2210056919.7 filed 1/18/2022 and to CHINA CN 202210056920.X filed 1/18/2022, under 35 U.S.C. 119(a)-(d). However, the certified copy of the foreign priority document is not accompanied by an English translation and statement of translation accuracy. Thus, foreign priority has not been perfected (see MPEP 2152.01 and 37 CFR 1.55). Until such time English translations of the foreign priority documents are made of record the effective filing date accorded the instant application 12/19/2022.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims are drawn to a composition comprising a pulchinenoside as active component. This judicial exception is not integrated into a practical application, and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The test regarding Patent Subject Matter Eligibility comprises the questions:
(1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter? For claims 1-10 the answer is “Yes” because the claim is to a composition.
(2) Prong 1: Does the claim recite or involve a judicial exception? The answer is “Yes” because the claimed composition has a pulchinenoside, which is a product of Nature. Wang et al (Industrial & Engineering Chemistry Research, 2012, 51(45), 14859-14866; cited in IDS filed 03/22/2023) teaches that pulchinenoside B4 and B5 are two major terpenoid saponins present in the roots of Pulsatilla chinensis (Bunge) Regel (Abstract; Introduction, page 14860, para 2.3).
(3) Prong 2A: Is the claim directed to a Law of Nature, A Natural Phenomenon (product of Nature) or an Abstract Idea? The answer is “Yes” because the claims are directed to a product of Nature. Pulchinenoside B4 and B5 are found in Nature.
Prong 2B: Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)? The answer is “No.” As set forth above, beyond the actual judicial exceptions, there are no additional elements that amount to significantly more.
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, 3 and 6-10 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.
Claim 1 recites ‘capable of promoting hair growth’. This recitation is not given patentable weight. A similar recitation is seen in claims 6-10. In addition, claims 6 and 8-10 recite ‘wherein the composition capable of promoting hair growth can be prepared into shampoo, etc. (claim 6), and ‘can be made into emulsion,’ etc. The claim intent is not clear. Therefore, claims 1, 6-10 are interpreted as composition claims.
In claim 3, in formula (II) for pulchinenoside B5, a double bond is missing in the third cyclohexane ring from the right side (see page 14860 in Wang reference cited above). This is also seen in formula (II) in the specification at para 0011. The claim is interpreted as drawn to formula (II) having a double bond at the said position.
Claims 9-10 are drawn to an application of pulchinenoside B4 or B5 in the preparation of a composition/drug capable of promoting hair growth and wherein the drug can be made in different forms. It is not clear if applicant is claiming a composition comprising the active agents pulchinenoside B4 or B5 or method of making the composition as a shampoo, etc. If a composition is intended then the intended use does not provide any limitation. If applicant intends a method of making claim, then the claim should be reworded accordingly with active steps for the method. Since the present claims do not provide active steps, the claims are interpreted as composition claims.
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) 1-3, and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (Industrial & Engineering Chemistry Research, 2012, 51(45), 14859-14866; cited in IDS filed 03/22/2023).
Wang et al teaches a composition comprising pulchinenoside B4 and B5 (page 14860, para 2.3). Aqueous ethanol is the auxiliary. Therefore, Wang et al anticipates instant claims 1-3 and 6-10.
Claim(s) 1-2 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al (EP 3747446 A1).
Yang teaches a pharmaceutical composition comprising anemoside B4, which is same as pulchinenoside B4, and pharmaceutical excipients (page 16, claims 7-8 of Wang and Formula I). this reads on claims 1-2 and 6-10. Therefore, Yang anticipates claims 1-2 and 6-9.
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.
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.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (Industrial & Engineering Chemistry Research, 2012, 51(45), 14859-14866; cited in IDS filed 03/22/2023).
Wang’s teaching is set forth above. Wang does not teach compositions comprising the effective amounts as in claims 4 and 5. However, it does teach diluting its compositions to prepare solutions of different concentrations (page 14860, para 2.3). This is a suggestion to make compositions having lower concentrations.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness 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."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings pharmaceutical compositions comprising pulchinenoside B4 and B5 are known in the art and there is a suggestion to prepare compositions having lower concentrations. Thus, it is obvious to make the compositions of pulchinenoside B4 and B5 having the concentrations as in claims 4 and 5.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. The artisan would be motivated to make the claimed compositions since Wang teaches that B4 and B5 were revealed to possess antitumor effects (page 14859-Introduction). The artisan would prepare the compositions as in claims 4-5 in order to look for compositions with minimum concentrations of B4 and B5 needed for antitumor effect.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 and 6-10 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2 and 4-5 of U.S. Patent No. 11,865,129 (‘129), as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,510,933 (‘933), and as being unpatentable over claims 1, 5 and 7 of U.S. Patent No. 11,793,822 (‘822). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are drawn to a composition comprising pulchinenoside B4.s
Claims 2 and 4-5 are drawn to a composition of anemoside B4 which is the same as pulchinenoside B4, with a pharmaceutical carrier, and in different forms.
Claims 1 and 5 recite a composition comprising anemoside B4, which is the same as pulchinenoside B4.
Claims 1, 5 and 7 of ‘822 recite a composition comprising saponin B4 having formulaI which is same as pulchinenoside B4, in the form of injection.
The claims of ‘129, ‘933 and ‘822 differ from the instant claims in that the instant claims are drawn to compositions comprising pulchinenoside B4, whereas the claims of ‘129, ‘933 and ‘822 use the same composition in a method of treatment. However, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention that the same compositions can be made irrespective of the method in which they are used.
In the instant the cited patents teach the composition applicant claims. Although the claims of the cited patents employ the compositions in a method, one of ordinary skill in the art would readily recognize that the compositions could be made as claimed. The use of known members of classes of active agents in compositions taught in the prior art is not seen to render the instantly claimed composition unobvious over the art. Once the composition has been shown to be old, the burden is on the applicant to present reason or authority for believing that the claimed compositions are different or could not be made.
Conclusion
Pending claims 1-10 are rejected
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693