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 .
DETAILED ACTION
The amendment to the claims filed after non-final office action on April 27, 2026 is acknowledged. Claims 24, 26-29, 31-35, 39-40 were amended, claims 1-23, 30, 41-42 were canceled and claims 24-29, 31-40, 43 are pending in the instant application. The restriction was deemed proper and made final previous office action.
Claims 29, 34-38, 43 are withdrawn as being drawn to a non-elected species/invention. Claims 24-28, 31-33, 39-40 are examined on the merits of this office action.
Withdrawn Rejections/Objections
The rejection of claims 28, 32 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed April 27, 2026.
The objections to claims 24, 26-28, 31-35, 39-40 are withdrawn in view of amendment of the claims filed April 27, 2026.
Maintained/Revised Rejections
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 24-28, 31-33, 39-40 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11332754 B2 in view of OTSUKA (Otsuka, R., et al. Microbiol. Immunol. (2015), 59(1); 28-36 (first published Nov. 19, 2014); on IDS) and DANIELL (US 2011/0302675; Pub. Dec. 8, 2011; on IDS) and FETISSOVA (US 2007/0140990; Pub. Jun. 21, 2007, cited in Applicant’s IDS) and HAYACIBARA (Hayacibara, M. F., et al. Carbohydr. Res. (2004), 339; 2127-2137; on IDS). *all references cited previously.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A biofilm degrading composition harboring a nucleic acid encoding mutanase of SEQ ID NO:1 and at least one of dextranase and lipase, in a pharmaceutically acceptable carrier” (see claim 24). The instant application further claims “produced in a plant plastid and comprising a plant remnant, wherein the plant remnant is freeze dried” (claim 25); glucoamylase (claim 28); antimicrobial (claim 31); fluoride (claim 32); chewing gum as a carrier (claim 33); wherein the plant remnants are from tobacco or lettuce plant (claim 39); a ratio of 5:1 dextranase and mutanase.
US Patent No. ‘754 claims “A method for increasing translation of a transgene encoding a protein of interest in a chloroplast, said method comprising: a) analyzing the native sequence of a nucleic acid encoding said protein of interest and replacing codons in said sequence with those preferentially used in psbA genes in chloroplasts in higher plants; b) producing a synthetic, codon optimized sequence and cloning said sequence into a chloroplast transformation vector, said synthetic sequence being operably linked to 5′ and 3′ regulatory elements suitable for expression in said chloroplast; c) transforming a target plant with said vector, under conditions whereby said protein of interest is expressed, wherein replacing said codons causes at least a two-fold increase in protein expression relative to expression levels observed using the native sequence, wherein the vector encodes a synthetic mutanase encoded by SEQ ID NO: 25.” SEQ ID NO:25 is the identical codon optimized mutanase of the instant claims. US Patent No. ‘754 further claims further comprising harvesting and lyophilizing leaves from said plant, said lyophilized leaves comprising the protein of interest” (see claim 3) and wherein the plant is edible that expresses the protein (see claim 6).
US Patent No. ‘754 is silent to the peptide being in combination with dextranase or lipase, an additional enzyme with antimicrobial activity, CHX or fluoride (claim 32), chewing gum, plant remnants from tobacco or lettuce plant and the ration of dextranase and mutanase (instant claim 40).
Ostsuka teaches that the use of both mutanase and dextranase to control dental plaque is known, and that the combination of mutanase and dextranase in combination is more effective than either enzyme alone (p. 29, 1st col.). Ostsuka teaches that chimeric mutanase-dextranase had a better inhibitory effect on biofilm formation than either enzyme alone ('Results'; Figs. 2-3). Thus, Ostsuka teaches the concept of using both mutanase and dextranase to successfully (and synergistically) treat oral biofilms.
Fetissova discloses oral care compositions for biofilm disruption (title; abstract). The compositions can be in the form of a chewing gum ([0073], [0084]). Fetissova teaches that enzymatic plaque disruption agents are suitable for inclusion in the oral compositions. The enzyme plaque disruption agents include glucoamylase, dextranase, and mutanase ([0050]).
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known
herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two each known to be useful for the same purpose (antimicrobials) along with any third or fourth antimicrobial or enzyme such as glucoamylase, with a reasonable expectation that at least here will be an additive effect.
Furthermore, In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a glucoamylase along with mutanase and dextranase since all of these enzymes were known as plaque reduction agents prior to the instant application. Since Fetissova teaches all of glucoamylase, mutanase, and dextranase as suitable plaque reduction agents for oral (e.g., chewing gum) compositions, Fetissova effectively establishes these agents to be functional equivalents. It is noted that the MPEP states that "An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." See MPEP § 2144.06(II).
Furthermore regarding being produced in lettuce and/or comprising a plant remnant, Daniell I discloses antimicrobial compositions containing one or more peptides that have been expressed in chloroplasts (title; abstract). Daniell teaches both lettuce and tobacco may be used as suitable plant expression systems ([0004], [0022], [0027], [0063]; claim 11). The compositions may optionally include a plant remnant ([0036]; claim 5). It would have been obvious to one of ordinary skill in the art to produce the protein in lettuce and include a plant remnant in the composition given it is known in the art for the purpose and US Patent No. ‘754 claims the mutanase being expressed in edible plants.
Regarding the ratio in instant claim 40, Hayacibara teaches on the influence of mutanase and dextranase on the glucans synthesized by as Streptococcal species, such as in dental plaque (title; abstract). Hayacibara teaches that the presence of 10 units of mutanase and 50 units of dextranase (i.e., a 5:1 ratio of dextranase to mutanase) were sufficient to reach the plateau in reducing the total amount of glucans synthesized by the bacteria studied (p. 2135, under '4.3. Synthesis of glucan').
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used mutanase and dextranase in a ratio of 5:1. One would have been motivated to do so since this ratio is taught as sufficient to reach the plateau in reducing the total amount of bacterial glucans.
Response to Applicant’s Arguments
Applicants argue “As a preliminary matter, Applicant notes that the '754 patent only includes 7 claims. Accordingly, it is Applicant's understanding that the claims are rejected over claims 1-7 of U.S. Patent No. 11,332,754 B2. Applicant respectfully traverses the rejection raised by the Examiner. In particular, Applicant submits that the pending claims are patentably distinct from those of the '754 patent.
The claims of the '754 patent claims methods of increasing translation of a transgene encoding a protein of interest in a chloroplast. In contrast, the claims of the instant application covers a biofilm degrading composition comprising a combination of mutanase with either dextranase or lipase. In the Restriction Requirement issued on September 1, 2020 during the prosecution of the '754 patent. The Examiner indicated that the subject matter encompassed by these two groups of claims are independent or distinct from one another because the present claims have a separate utility from those of the '754 patent.
More specifically, during the prosecution of the '754 patent, Applicants elected Group 1. At page 4 of the September 1, 2020 Restriction Requirement, the Examiner states that Groups 2-5 "have distinct structures and biochemical functions and share no commonality with the method of Group I, other than that they could be one of the generic proteins of interest as recited in the method steps.... Accordingly, the groups lack the same or a corresponding special technical features as to form a single general inventive concept." Accordingly, Applicant respectfully submits that these claims are patentably
distinct from one another and that the pending rejection is improper. Reconsideration and withdrawal of this rejection is respectfully requested.
Applicant’s Arguments have been fully considered but not found persuasive. This issue under nonstatutory obviousness type double patenting is not whether the claims are drafted in different statutory classes or recite different claim formats. Rather, the issue is whether the pending claims are patentably distinct from the claims of the reference patent. The rejection does not rely solely on the claim format of US patent ‘754. As explain in the office action, the patented claims encompass the same codon optimized mutanase sequence and plastid expression platform relied upon by the instant claims. The additional limitations directed to oral care compositions and combinations with dextranase, lipase, glucoamylase, antimicrobials, fluoride, chewing gum carriers, plant remnants and specific enzyme rations are taught or suggested by Otsuka, Fetissova, Daniell, and Hayacibara.
Applicants argue that the claims are patentably distinct because the patented claims concern chloroplast expression while the instant claims concern biofilm degrading compositions. Applicant’s arguments are not found persuasive. The rejection acknowledges that the claims are not identical. However, being identical is not required for a proper obviousness type double patenting rejection. The relevant inquiry is whether one of ordinary skill in the art would have found the claimed subject matter to be an obvious variation of the patenting claims. As set forth in the above rejection, the patented claims provide the codon optimized mutanase sequence expressed in plant chloroplasts. The cited references teach the use of mutanase in combination with dextranase and other plaque controlling enzymes in oral care compositions for biofilm degrading. Thus, one of ordinary skill in the art would have found it obvious to formulate the patented mutanase product into the claimed biofilm degrading compositions.
Applicants further argue that during prosecution of the other application, a restriction requirement stated that the groups possessed distinct structures, biochemical functions and lacked a common special technical feature. Applicants arguments are not persuasive. A restriction requirement is made for purposes of examination efficiency and does not constitute a determination that claims are patentably distinct for purpose of nonstatutory obviousness type double patenting. The standards governing restriction practice differ for those governing obviousness type double patenting . A finding that inventions are independent and distinct for restriction purposes does not preclude a later determination that one claimed invention is an obvious variant of another claimed invention. The mere existence of a restriction requirement in another application doesn’t overcome a properly made obviousness type double patenting rejection.
Applicants argue that the inventions have separate utilities. Applicants argument is not persuasive. The existence of different utilities or intended uses does not establish patentable distinctness where the claimed subject matter would nevertheless have been an obvious modification of the patented invention. The rejection is based on the finding that the pending claims utilize the same codon optimized mutanase sequence and plant expression technology claimed in the patent and merely incorporate additional components or formulation features known in the art for the same general purpose of oral biofilm reduction and plaque control. Applicant has not provided evidence that the claimed compositions exhibit unexpected results, criticality or any property sufficient to establish patentable distinctness over the patented claims. Thus, the rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654
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