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 . Preliminary amendment filed on 05/29/2024 has been entered. Claims 6-13 are new. Claims 1-13 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/JP2021/043777 filed on 11/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/03/2024 has been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “size distribution is less than or equal to 0.30%”, which is identical to the preceding claim 1, and thus not further limiting the preceding claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-4 and 6-13 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 1-4 and 6-13 recite a hyaluronic acid powder comprising hyaluronic acid particles comprising hyaluronic acid and/or a salt thereof having an average molecular weight of greater than or equal to 1,500,000, wherein a content of the hyaluronic acid particles having a particle diameter of less than or equal to 100 μm is 0 mass% to 35 mass% based on a total mass of the hyaluronic acid powder, which is a product 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 the recited particle content, particle size, or particle size distribution (i.e., a relative standard deviation is less than or equal to 0.30%) changes the structure, function, or other properties of the hyaluronic acid and/or a salt thereof in any marked way. Instead, the hyaluronic acid and/or a salt thereof retains its naturally occurring structure and properties (e.g., glucosamine or extracellular matrix). 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, hyaluronic acid powder or dry particle was well-understood, routine and conventional in the field, as evidenced by the reference under the 103 rejection below. The recitation of specific particle content, particle size, or particle size distribution (i.e., a relative standard deviation is less than or equal to 0.30%) does not affect this analysis, because it was also well-understood, routine and conventional at the time to prepare specific particle content, particle size, or particle size distribution, e.g., to achieve commercially acceptable forms. Thus, the hyaluronic powder of specific particle content, particle size, and/or particle size distribution, 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) Claim 5 is 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 process (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claim 5 recites a method for selecting a raw material hyaluronic acid powder, which encompass a mental process of selecting a raw material hyaluronic acid powder from a list of hyaluronic acid powders, and thus are natural phenomenon. 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 deemed that this judicial exception is not integrated into a practical application because there is no indication that the selection change the claimed method in any marked way. Instead, the selection achieves the intended purpose. Thus, the claimed process as a whole does not display markedly different characteristics compared to the closest naturally occurring process. Accordingly, the Step 2A (Prong two) is NO because this judicial exception is not integrated into a practical application. 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, selection of hyaluronic powder having specific particle content and comprising specific molecular weight of hyaluronic acid were well-understood, routine and conventional in the field, as evidenced by the references under the 102 and 103 rejections below. The recitation of specific particle size and particle size distribution does not affect this analysis, because it was also well-understood, routine and conventional. Thus, the claimed method, 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 “natural phenomenon” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
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.
(I) Claims 5 is 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 Catanese et al. (IT201800002509, published on Aug. 08, 2019 and provided with English translation for citation, hereinafter referred to as Catanese ‘509, also listed in IDS filed on 07/03/2024).
With regard to structural limitations “A method for selecting a raw material hyaluronic acid powder comprising hyaluronic acid particles, wherein the hyaluronic acid particles comprise hyaluronic acid and/or a salt thereof having an average molecular weight of greater than or equal to 1,500,000, and wherein a content of the hyaluronic acid particles having a particle diameter of less than or equal to 100 μm is 0 mass% to 35 mass% based on a total mass of the hyaluronic acid powder” (claim 5):
Catanese ‘509 disclosed a high molecular weight hyaluronic acid having a molecular weight greater than 500,000 Da, even more specifically greater than 1,500,000 Da. In possible implementations, hyaluronic acid has a molecular weight greater than 3,000,000 Da. For example, the molecular weight of hyaluronic acid can be between about 1,000,000 Da and about 3,000,000 Da, in particular between about 1,500,000 Da and about 2,500,000 Da, plus in particular between about 1,600,000 Da and about 2,300.00 Da, even more particularly between about 1,800,000 Da and 2,200,000 Da. The molecular weight ranges identified above in accordance with possible embodiments allow to ensure the best film or patina formation, with an optimal effect of mechanical properties and filming effect on the gastric mucosa. In embodiments, the hyaluronic acid is in powder form, in particular the hyaluronic acid can be micronized, for example with an average particle size, or particle size, comprised between about 60 mesh (250 micrometers) and about 80 mesh (177 micrometers) (page 5/8, para. 5-7).
Thus, these teachings of Catanese ‘509 anticipate Applicant’s claim 5 because a hyaluronic acid powder having a molecular weight between about 1,500,000 Da and about 2,500,000 Da, and an average particle size between 177 µm and 250 µm is particularly selected to ensure the best film formation on the gastric mucosa, described above, and would also achieve the intended purposes, including “a content of the hyaluronic acid particles having a particle diameter of less than or equal to 100 μm is 0 mass% to 35 mass% based on a total mass of the hyaluronic acid powder” and “used in a method for producing cross-linked hyaluronic acid and/or a salt thereof”. Or, in an alternative, skilled artisan would select particles between 177 µm and 250 µm with minimal size variation.
(II) Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Catanese et al. (IT201800002509, published on Aug. 08, 2019 and provided with English translation for citation, hereinafter referred to as Catanese ‘509, also listed in IDS filed on 07/03/2024) in view of Yamazaki et al. (US 2016/0333119, Nov. 17, 2016, hereinafter referred to as Yamazaki ‘119). Claim 5 is rejected here because it has been rejected by the primary reference under 102 above. Thus, the above disclosure of Catanese ‘509 is incorporated in its entirety here.
Catanese ‘509 did not explicitly disclose the limitation “a relative standard deviation (= standard deviation/average particle diameter (micrometer) x 100, see the Specification, p. 6, [0020]) of a particle size distribution is less than or equal to 0.30%”, required by claims 1 and 2.
Yamazaki ‘119 disclosed that standard deviation of particle diameters is an indicator of a variation of particle diameters of the hyaluronic acid and/or the salt thereof. When the standard deviation of particle diameters of the hyaluronic acid and/or the salt thereof may be 0.1 or more and 0.3 or less, and is preferably 0.15 or more and preferably 0.25 or less, a small variation of particle diameters can increase a density. The hyaluronic acid of Comparative Example 8 was obtained without the anion-exchange resin treatment step, and hence the content of chlorine was more than 1 mass %, and additionally, the standard deviation of particle diameters was higher than 0.3, indicating that the shapes of the particles were not uniform (page 4/21, [0056]; page 17/21, [0237]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to combine the selection of a hyaluronic acid powder having a molecular weight between about 1,500,000 Da and about 2,500,000 Da, and an average particle size between 177 µm and 250 µm as taught by Catanese ‘509 with the method for reducing the standard deviation of hyaluronic acid particle diameter to 0.3 or less in view of Yamazaki ‘119 to provide dense and uniform film formation, described above. Thus, one of skill in the art would have a reasonable expectation that by combining the selection of a hyaluronic acid powder having a molecular weight between about 1,500,000 Da and about 2,500,000 Da, and an average particle size between 177 µm and 250 µm as taught by Catanese ‘509 with the method for reducing the standard deviation of hyaluronic acid particle diameter to 0.3 or less in view of Yamazaki ‘119, one would achieve Applicant’s claims 1-13. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 [R-01.2024] [II.A].
The powder or method of Catanese ‘509 in view of Yamazaki ‘119 meets all structural limitation of claimed powder or method, and would also carry the same properties or achieve the intended purposes, including “a content of the hyaluronic acid particles having a particle diameter of less than or equal to 100 μm is 0 mass% to 35 mass% (or 0 mass% to 5 mass%; or 0 mass% to 30 mass%) based on a total mass of the hyaluronic acid powder”, “the content of the hyaluronic acid particles having a particle diameter of less than or equal to 155 micrometers is 0 mass% to 55 mass%”, and/or “the content of the hyaluronic acid particles having a particle diameter of less than or equal to 190 micrometers is 0 mass% to 60 mass%”, required by claims 1, 3, 5, 6, 12, and 13.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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