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 .
Priority
The present application is a Continuation of International application PCT/CN2022/143803 filed 12/30/2022, which claims the benefit of Foreign application CN202210109256.0 filed 01/28/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, although it is noted that no English translation was provided.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 07/26/2024, in the matter of Application N° 18/784,951. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-12 are pending.
Claims 1-12 are presented for examination and rejected as set forth below.
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.
Claims 1, 3-5, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (WO2020140707A1; note that family member US20210322284A1 is used for translation), and in further view of Li (Adv. Mater., 2019) and Wang (Biochemical and Biophysical Research Communications, 2009).
Applicant’s claims are directed to a biomineralization material for treating dentin hypersensitivity and promoting epitaxial growth of enamel, comprising the following raw materials in parts by weight: 5-72 parts of a film-forming protein or a PEGylated film-forming protein, 4-67 parts of a water-soluble disulfide bond exchanger and 1-21 parts of a pH regulator. Note that the intend use(s) of a composition (throughout claim set; such as “mouthwash”, “toothpaste”, “pit and fissure sealant”, etc.) is not considered to contribute to patentability of the composition, but it is the structure of the composition itself that provides patentable weight (although the Examiner acknowledges general structural distinctions of a toothpaste vs. mouthwash, for example).
Note, all ingredients featured as “optionally” by the claim set (see claims 2-12) are not considered required by the claim set, because they are optional components (e.g., in claim 2, “and optionally, 30-50 parts of the film-forming protein or a PEGylated film-forming protein, 10-50 parts of the water-soluble disulfide bond exchanger and 6-20 parts of the pH regulator”; in claim 3, “optionally one or more of cysteine and glutathione”; etc.). Thus, the BRI and a suitable interpretation of the claim set is to disregard the “optionally” included components. Further note that replacement of “optionally” with “particularly”, “preferably”, “such as”, etc. would not be a suitable fix, because these terms construe exemplary language and are indefinite (see MPEP 2173.05(d). Notably “preferably” is found in the “optionally” phrase of claims 4 and 11-12.
Further note, that places that have “optionally” tend to also have narrow and broad ranges, and if the term “optionally” were removed in these cases, then the multiple narrow and broad ranges would be considered indefinite (See MPEP § 2173.05(c)).
Also, note that the “optionally” of “use method” of claim 8, if required by the claim (i.e., by removing “optionally”), would improperly combine a composition and a non-statutory patent category (i.e., “use” “method” and “composition” would render the metes the bounds of the invention as indefinite. See In re Steele, 305 F.2d 859,134 USPQ 292 (CCPA 1962) (it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions).
Note, the abbreviations of the instant Application for reference, defined in the Art: HEPES (2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid) and TCEP (tris(2-carboxyethyl)phosphine).
Yang (‘284) teaches an oral dental desensitizer, comprising a PEG-modified protein, TCEP HCl, calcium chloride, and a pH regulator (abstract), that can also promote remineralization [0004].
Regarding claim 1 and 11: Yang teaches a dental desensitizer, including, by weight: 1-20 parts of a protein modified by polyethylene glycol (reads on the instant 5-72 parts) such as lysozyme (reads on protein of claims 1 and 11) (Yang – claim 3); 1-10 parts of tris(2-carboxyethyl) phosphine hydrochloride (TCEP HCl) (reads on the instant 4-67 parts); and 2-20 parts of a pH regulator (reads on the instant 1-21 parts) (overlaps the ranges of claim 1 and reads on the open-ended “comprising” language) (abstract, Yang – claim 1). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). 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.”).
Regarding claim 4: Yang teaches PEGylated lysosome, etc. (Yang – claims 1-4).
Regarding claim 5: Yang teaches the pH regulators sodium bicarbonate, etc. (Yang – claims 7-8). Note that the basic pH regulator also makes the free form of TCEP obvious, via the known neutralization reaction of TCEP HCl.
In summary, Yang teaches the obviousness of the composition of instant claim 1 (except for the water-soluble disulfide bond exchanger). Thus, Yang does not teach the water-soluble disulfide bond exchanger (e.g., cysteine or glutathione) (instant claims 1, 3 and 12).
Li teaches TCEP has the ability to reduce the intramolecular disulfide bonds of lysosome (and additionally lyso-PEG, or pegylated lysozyme, which demonstrates functional equivalence) to produce a protein nanofilm (abstract; pg 1, paragraph 2), which serves as an effective antifouling platform to resist oral bacteria attachment and to remineralize teeth (abstract).
Wang teaches DTT, glutathione, and cysteine are capable of reducing lysozyme similarly to TCEP, whereby disulfide disruption and structural unfolding of lysozyme occurs (abstract; pg 639, ‘introduction’; pg 642, paragraphs 1-2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the TCEP reducing agent used in Yang’s compositions that is used to promote sealing of dentine tubules, with the thiol-based reducing agents (i.e., DTT, glutathione, and cysteine) taught by Wang, because Li teaches the mechanism of the film-forming process that allows for effectiveness of Yang’s disclosure (i.e., aggregation of lysozyme and lyso-PEG), whereby Wang teaches that DTT, glutathione, and cysteine are also capable of reducing lysozyme (i.e., functionally similar to TCEP), in order to unfold lysozyme and induce fibrillation (abstract; pg 640, ‘introduction’; pg 642, paragraphs 1-2). Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). Therefore, the use of these thiol reducing agents (i.e., DTT, glutathione, and cysteine) in place of the TCEP reducing agent used by Yang is prima facie obvious due to the functional equivalence of these agents in unfolding proteins to induce fibrillation, as taught by Wang.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (WO2020140707A1; note that family member US20210322284A1 is used for translation), Li (Adv. Mater., 2019) and Wang (Biochemical and Biophysical Research Communications, 2009), as applied to 1, 3-5, and 11-12, and in further view of Yang (WO2020140706A1; note that family member US20210322292A1 is used for translation).
As discussed above, the combined Prior Art teaches the obviousness of the composition of instant claim 1, including the water-soluble disulfide bond exchanger, in the instant amounts. However, the Art does not teach the narrowed amounts (i.e., specifically the instant 30-70 parts of protein and the instant 20-67 parts of the disulfide bond exchange) (instant claim 2), the mouthwash (instant claims 6-7), the HEPES buffer and instant mass ratio (instant claims 8 and 10), and the toothpaste (instant claim 9).
Yang (‘292) teaches an oral dental mineralization agent (abstract, [0003]), comprising, 5-50% of a film-forming protein (reads on the instant 30-70 parts of claim 2), 4-20% of a tris(2-carboxyethyl) phosphine hydrochloride (TCEP HCl) (reads on the instant 20-67 parts of claim 2; which is functionally equivalent to the instant disulfide bond exchanger within the context of the invention, as taught by Wang and Li above), and 1-10% of a pH regulator (Yang – claim 1). Furthermore, Yang teaches the obviousness of these compositions for use with HEPES buffer [0008] (instant claim 8) for mouthwashes and toothpastes (Yang – claim 7-11) (instant claims 6-7 and 9). Furthermore, Yang teaches the ratio of mineralization agent to HEPES as 1 mg: 4-15 mL (i.e., about 0.001 g agent to 4-15 g aqueous HEPES solution, corresponds to a 0.001:4-15 mass ratio), where different excipient (reads on the instant “additives”) such as saccharin sodium, sorbose, pigments [0010-0012] are added in a 1:2 to 1:5 ratio of mineralization agent to the excipient [0011].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of the combined Prior Art with the additional details provided by Yang (‘292), because both Yang (‘284) and Yang (‘292) share a large number of overlapping ingredients for the purpose of dental treatment that operate by the same mechanism of protein unfolding and film forming (e.g., with lysozyme or PEG-lyso), as discussed by Li. Thus, Yang (‘292), merely expands on the potential for adapting this film-forming mechanism to additional dental-based products, incorporating optimized ratios of ingredients for these products in relation to the combined Prior Art.
Specifically, regarding instant claim 10 (i.e., the instant ratio of biomineralization material to HEPES buffer, as a “mass ratio of 1: 0.1-5”): The HEPES solution of Yang (‘292) is a buffer (i.e., a pH regulator) [0008]. Furthermore, Yang (‘284) teaches the mass ratio of 1-20 parts of a protein, 1-10 parts of TCEP, and 2-20 parts of a pH regulator (e.g., a buffer) [0031] (abstract, Yang – claim 1). Thus, it would be obvious to use HEPES as the pH regulator of Yang (‘284), and also mixtures of pH regulators are taught by Yang (Yang – claim 7-8).
Note, that the intended use of a “pit and fissure sealant” of claim 10 does not provide patentable weight in terms of a composition: Particularly, a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Yang (WO2020140707A1; note that family member US20210322284A1 is used for translation), Li (Adv. Mater. 2019, 31, 1903973), Wang (Biochemical and Biophysical Research Communications, 2009), and Yang (WO2020140706A1; note that family member US20210322292A1 is used for translation).
claims 1-11 of Patent No. US11701320
claims 1-6 of Patent No. US12048754
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach a protein and/or protein modified by PEG, a reducing agent, and a pH regulator. The patents differ only significantly by not including the water-soluble disulfide bond exchanger of the instant claims.
This is remedied by Li and Wang, who teach the mechanism of Yang’s disclosures that are based on the reduction and unfolding of a protein and/or a pegylated protein in order to form films on teeth, whereby reagents such as DTT, cysteine, and glutathione are discussed as suitable reducing agents for this process. One of ordinary skill in the art would have been motivated to modify the teachings of the patents because DTT, cysteine, and glutathione are taught by the Art to functionally perform the same role as TCEP in both patent disclosures, and: the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Furthermore, the Yang WO disclosures teach gaps within the instant claims as obvious, that are not covered by the claim set of Patent ‘320 and/or ‘754 (see similar rationale in 103 rejection above).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 5/19/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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