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
Applicant’s election without traverse of Claims 1-11 and 16-19 directed to uses of microcapsules of nitrate and vitamin C in the reply filed on 27 April 2026 is acknowledged.
Status of the Claims
Claims 1-19 are pending.
Claims 12-15 are withdrawn from consideration as directed to a non-elected invention.
Claims 1-11 and 16-19 are presented for examination and rejected as set forth in greater detail below.
Priority
The instant application is a National Stage entry of International application PCT/CN2022/083009 filed 25 March 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to Chinese national application 202110951708.5 filed 19 August 2021.
Claim Interpretation
Applicants Claims are directed to the use of a microcapsule of nitrate and vitamin C “in the preparation of a medicament” having a wall material encapsulating a combination of vitamin C and nitrate in defined molar ratios. As set forth above, the present claims corresponding to a non-statutory “use” category of invention absent any affirmative steps recited to manipulate the components recited, either to formulate a composition or to treat a disease or disorder by the administration of such a composition, the broadest reasonable interpretation of the actual language provided by the applicants is that of the composition which is described by the components recited in the relative amounts recited. Dependent claim 2 recites a manner in which the compositions may subsequently be used, which fails to further limit the composition claimed. Additional dependent claims limit the ratio of vitamin C to nitrate, or the identity of the nitrate component, or the components to be present in the wall material. Claim 16 indicates the microcapsules have a defined particle size, and Claims 17-19 describe the physical form the compositions are to take.
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 1-11 and 16-19 are rejected under 35 U.S.C. § 101 as being drawn to “use” claims, which are non-statutory claims, as defined in 35 U.S.C. § 101. See Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967).
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.
Claims 1-11 and 16-19 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.
More specifically, a claim is rendered indefinite when said claim merely recites a “use” without any active, positive steps delimiting how this use is actually practiced. See MPEP 2175.03(q). Here, none of the “use” claims of record recite any affirmative method steps to either “use,” “administer,” or “prepare” the microcapsule compositions described within the claims. Applicants are required to redraft the aforementioned use claims to reflect a proper statutory category of invention, which for purposes of compact prosecution is being treated as claims directed to a composition containing the recited elements of the claims.
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.
Claims 1-6 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN110327367)(of record)(machine translation provided).
Wang describes compositions for the delivery of combinations of nitrate and vitamins. Pg.1. The sodium nitrate of Claims 1, 2, 5, and 6 is particularly identified by Wang as a useful nitrate, as is the Vitamin C, particularly in ratios of between 10:1 and 1:10, ratios overlapping and therefore rendering obvious the ranges of Claims 3 and 4. Pg.2; See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Wang indicates that pharmaceutically acceptable forms of administration such as tablets and capsules of Claims 17-19 may be used to formulate the combinations of nitrate and vitamins. Pg.3. Liposomes having a diameter of 150-200nm are a particularly preferred form of the nitrate and vitamin preparation; while falling outside the range set forth by Claim 16, it must be remembered that it has long been held that mere differences in size, absent evidence of unexpected results associated with such a change, cannot serve to patentably distinguish a claimed composition from a prior art composition having different dimensions. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Indeed, differences in particle sizes will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.).
The specific combination of features claimed is disclosed within the broad teachings of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of sodium nitrate and vitamin C in the claimed ratios provided as nanoparticulate liposomes within a tablet or capsule, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of sodium nitrate and vitamin C in the claimed ratios provided as nanoparticulate liposomes within a tablet or capsule from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1-9, 11, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang as applied to claims 1-6 and 16-19 above, and further in view of Hu (U.S. PGPub. 2015/0366814) and Mensonides (WO2019/101904).
Wang, discussed in greater detail above, suggests nanoparticulate liposome compositions combining sodium nitrate and vitamin C in the claimed ratios provided within a tablet or capsule.
Wang does not, however, teach a liposome having a shell of pectin and sodium carboxymethyl cellulose surrounding a chitosan core to be used as the liposomal nanocarrier.
Hu describes capsules comprising a shell of a film-forming polymer and one or more enteric acid-insoluble polymers. [0073]. While embodiments of these shells incorporate between 20-40% film-forming polymer, and between 2-7% anionic polymer. [0078] “Table 1.” While these ranges fall outside those recited by Claims 10 and 11, it must be remembered that when the general conditions of a claim are disclosed by the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See Aller, supra. As such, given the generic teaching of combinations of film-forming polymers and anionic polymers in the formulation of capsule shell walls, the amounts and ratios of Claims 10 and 11 cannot be said to patentably distinguish the instant claims from the prior art. Pectin and carboxymethyl celluloses are described as suitable enteric anionic polysaccharides for use in the formation of these capsule shells. [0075]. While the sodium carboxymethylcellulose of the instant claims is not specifically identified as either an anionic enteric polymer or film-forming agent by Hu, this is cured by the teachings of Mensonides, which indicates that at the time the instant application was filed, sodium carboxymethylcellulose was, in fact, known in the pharmaceutical encapsulation arts as a film-forming polymer for the encapsulation of pharmaceutical active agents. (Mensonides, Pg.19, L30 – Pg.20, L.4). Hu identifies Chitosan as among the hydrophilic polysaccharides useful as the matrix fill of the enteric coated capsules described. [0135; 0155-56].
It therefore would have been prima facie obvious to have used chitosan as the core of the compositions of Wang, with the combination of pectin and sodium carboxymethylcellulose of the instant claims as the capsule shell wall to encapsulate combinations of sodium nitrate and vitamin C. This is because at the time the instant application was filed, chitosan was known to be useful as a pharmaceutical capsule fill material compatible with pharmaceutical active agents, and combinations of each of pectin and sodium carboxymethylcellulose were known to serve as capsule shells. This is because it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Claims 1-11 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, Hu, and Mensonides as applied to claims 1-9, 11, and 16-19 above, and further in view of Liu (CN110432377)(machine translation provided).
Wang, Hu, and Mensonides, discussed in greater detail above, suggest using chitosan as the core of a nanoparticle composition with a combination of pectin and sodium carboxymethylcellulose of the instant claims as the capsule shell encapsulating combinations of sodium nitrate and vitamin C.
However, nothing of Wang, Hu, and Mensonides suggest using chitosan with a molecular weight of 3000 as the fill material.
This is cured by Liu, which indicates that chitosan having a molecular weight of 3000 kDa is known to be useful as nanoparticle-forming gels for delivery of pharmaceutical active agents.
It therefore would have been prima facie obvious to have used chitosan with a molecular weight of 3000 as the fill material of the compositions suggested by the teachings of Wang, Hu, and Mensonides, owing to the fact that Liu indicates that chitosan having these properties was known to be useful as a nanoparticulate fill material
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 1-11 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/685,165 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because while the copending claims recite “product-by-process” language absent from the instant application, the compositions resulting from such claims appear to overlap or anticipate the compositions presently claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
Prosecution Insights