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 .
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.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112, Second Paragraph
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 1-15 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.
Regarding broad to narrow limitation, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “vitamin C and nitrate, 0.3-1.2 parts by weight”, and the claim also recites (in total) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. To overcome this rejection, the parathesis can be removed from the claim.
Claim 9 is indefinite because it recites the limitation “high pressure” in line 4, but it is not clear what pressure it must be to be considered “high” and support is not found in the specification.
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.
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.
Claims 1-6, 8-10, and 12-15 are rejected under 35 U.S.C. 103 as being as being obvious over Hu et al. (US 2015/0366814 A1) in view of Wang (CN 110327367 A).
Regarding claim 1, Hu discloses soft capsules comprising a shell and a matrix fill encapsuled in the shell [abstract]. Hu discloses that the shell material includes at least one or more anionic polysaccharide such as carboxymethyl cellulose and pectin [0028] [0075]. The weight percentage range of anionic polymer in the capsule composition is about 2 to about 7 wt.% [0078] [0085]. Specific amounts of pectin are disclosed in Table 9, such as 2.6, 2.87, and 3.3 wt.% based on the weight of the capsule formulation [0248]. Hu discloses the matrix fill includes an active ingredient such as vitamin C [0167]. The active ingredient comprises about 1-80 wt.% of the matrix fill mass [0175]. Hu also discloses the matrix fill includes the hydrophilic polysaccharide chitosan in an amount of 2 to about 10 wt.% of the matrix fill [0135] [0257]. The ratio of the shell composition to the fill composition is, for example, around 1:0.03 [0260]. Hu discloses that the capsules of the disclosure are used to reduce the onset of gastric irritation, gastric reflux [0216] and for treating fatty liver disease [0243].
Generally, it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, the claimed elements (e.g., carboxymethyl cellulose, pectin, vitamin C, and chitosan) were known in the prior art (e.g., Hu) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a capsule) to one of ordinary skill in the art. MPEP 2143.A.
Hu does not teach nitrate or that the molar ratio of vitamin C to nitrate ions ranges from 1:1 to 1:5.
Wang teaches a nitrate and vitamin containing preparation, which can be in the form of a capsule (abstract; English translation, pg. 3, paragraph 5). The nitrate is most preferably sodium nitrate and the vitamin is most preferably vitamin C and the ratio of the amount of nitrate and the vitamin is 5:1-1:5 (English translation, pg. 2, bottom – pg. 3, top). Wang teaches that the composition comprising nitrate and vitamin is used to increase the nitrate content in blood which is beneficial because increasing the nitrate content in the blood can regulate gastrointestinal function, improve and/or treat the stomach and intestine, and prevent liver degeneration and liver steatosis (English translation, pg. 3, paragraphs 10-11).
Since Hu generally teaches capsules for the treatment of diseases such as those of the gastrointestinal tract and liver, it would have been prima facie obvious to one of ordinary skill in the art to include nitrate and vitamin C in a ratio of 5:1-1:5 because Wang teaches that the composition comprising nitrate and vitamin in this ratio is used to increase the nitrate content in blood. One of ordinary skill in the art would be motivated to do so because Wang teaches that increasing the nitrate content in the blood can regulate gastrointestinal function, improve and/or treat the stomach and intestine, and prevent liver degeneration and liver steatosis (English translation, pg. 3, paragraphs 10-11).
In regards to the amounts of the individual components, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Further regarding claim 1, while Hu teaches carboxymethyl cellulose, Hu does not explicitly disclose “sodium carboxymethyl cellulose” as recited in claim 1. Nevertheless, there is a reasonable expectation that structurally similar species have similar properties. See MPEP 2144.08. It would be reasonably expected that sodium carboxymethyl cellulose would have similar properties as carboxymethyl cellulose.
Further regarding claim 1, the limitation of the preparation of the microcapsule is interpreted as a product-by-process limitation. Even though the product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the combined teachings of Hu and Wang read on the claimed microcapsule. As such, the patentability of the instant microcapsule does not depend on its method of production, and the Applicant' s limitation regarding the method of preparation is not patentable, in view of Hu and Wang.
Claims 2-3 are rendered prima facie obvious because it would have been obvious to include nitrate and vitamin C in a ratio of 5:1-1:5, within the composition of Hu, as taught by Wang, as discussed above. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 4-5 are rendered prima facie obvious because it would have been prima facie obvious to include nitrate, as taught by Wang, for the reasons discussed above (i.e., increasing the nitrate content in the blood to regulate gastrointestinal function, improve and/or treat gastrointestinal stress damage and prevent liver degeneration and liver steatosis), and Wang discloses the nitrate is most preferably sodium nitrate (English translation, pg. 2, bottom).
Regarding claim 6, Hu discloses that the shell material includes at least one or more anionic polysaccharide such as carboxymethyl cellulose and pectin. The weight percentage range of anionic polymer in the capsule composition is about 2 to about 7 wt.%. Specific amounts of pectin are disclosed in Table 9, such as 2.6, 2.87, and 3.3 wt.% based on the weight of the capsule formulation [0028] [0075] [0078] [0085] [0248]. Hu also discloses the matrix fill includes the hydrophilic polysaccharide chitosan in an amount of 2 to about 10 wt.% of the matrix fill [0135] [0257]. The ratio of the shell composition to the fill composition is, for example 1:0.03 [0260]. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of the amount of pectin, carboxymethyl cellulose, and chitosan have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum ratio via routine experimentation.
Claims 8-10 are interpreted as a product-by-process limitations. Even though the product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. As discussed above, the Applicant' s limitations regarding the method of preparation are not patentable, in view of Hu and Wang.
Claim 12 is rendered prima facie obvious because Hu discloses pharmaceutical composition further includes pharmaceutically acceptable excipients or additives [0071] [0153].
Claims 13-14 are rendered prima facie obvious because the compositions of Hu are clinically acceptable oral formulations [0047] [0177] [0072].
Claim 15 is rendered prima facie obvious because Hu discloses the formulations are in the form of capsules [abstract] [0047].
Claim 7 is rejected under 35 U.S.C. 103 as being as being obvious over Hu et al. (US 2015/0366814 A1) in view of Wang (CN 110327367 A) and further in view of Goncalves et al. (Polymers, 2021, 13:2466).
The 35 U.S.C. 103 rejection over Hu in view of Wang was previously discussed.
Regarding claim 7, Hu does not disclose that the chitosan is chitosan 3000.
Goncalves discloses chitosan with a molecular weight from 1-100 kDa (Table 5, pg. 14). Goncalves teaches that chitosan with molecular weights in this range are considered antimicrobial agents or additives in pharmaceutical compositions (pg. 19, paragraph 5).
Since Hu generally teaches a pharmaceutical composition, it would have been prima facie obvious to one of ordinary skill in the art to include chitosan with a molecular weight from 1-100 kDa within the teachings of Hu because Goncalves teaches chitosan with this molecular weight in a pharmaceutical composition. The ordinarily skilled artisan would have been motivated to use chitosan with this molecular weight because Goncalves teaches that chitosan with molecular weights in this range are antimicrobial agents or additives in pharmaceutical compositions (pg. 19, paragraph 5). A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 11 is rejected under 35 U.S.C. 103 as being as being obvious over Hu et al. (US 2015/0366814 A1) in view of Wang (CN 110327367 A) and further in view of Meiners et al. (US 2015/0158004 A1).
The 35 U.S.C. 103 rejection over Hu in view of Wang was previously discussed.
Regarding claim 11, Hu does not disclose that the microcapsules have a particle size of 850-1000 nm.
Meiners discloses capsules with a core/shell structure [abstract] [0001] where the capsules have a size from 1 µM up to 1 mm [0175]. Meiners teaches that capsules of this size are in accordance with the requirements and/or preferences for a consumer end product, such as pharmaceuticals [0175] [0181].
Since Hu generally teaches pharmaceutical capsules with a core/shell structure it would have been prima facie obvious to one of ordinary skill in the art to have a capsule size from 1 µM up to 1 mm because Meiners teaches this size of a pharmaceutical capsule with a core/shell structure. The ordinarily skilled artisan would have been motivated to use this size capsule because Meiners teaches that capsules of this size are in accordance with the requirements and/or preferences for a consumer end product, such as pharmaceuticals [0175] [0181]. A prima facie case of obviousness exists because of overlap, as previously discussed.
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.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent Application No. 18/685,073.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (microcapsule) recited in the claims of the copending application falls within the genus (microcapsule) recited in the claims of the instant application, and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
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/ASHLEE E WERTZ/Examiner , Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612