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
Claims 1-23, 30, 41-42 were previously canceled and claims 24-29, 31-40, 43 are pending in the instant application.
The restriction is deemed proper and was made FINAL in a previous office action. Claims 29, 34-38, 43 remain withdrawn from consideration as being drawn to a non-elected invention/species.
Claims 24-28, 31-33, 39-40 are examined on the merits of this office action.
*Prosecution is reopened. A review of the application with after final submission on December 15, 2025 has identified a previously unaddressed issue of double patenting. Accordingly, the prior office action is withdrawn as to finality, and prosecution is reopened to enter the following rejection. During an interview, the issue of double patenting and the possible filing of a terminal disclaimer were discussed; Applicant indicated that a terminal disclaimer would not be submitted.
Terminal Disclaimer
The terminal disclaimer filed on December 15, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11246819 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
The rejection of claims 24-28, 31-33, 39-40 on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11246819 B2 is withdrawn in view of the filing and approval of a terminal disclaimer on December 15, 2025.
New Objections
Claims 26-28, 31-35, 39-40 are objected to for the following informalities: The limitation of “the composition” should be replaced with “The biofilm degrading composition”.
In claim 24, a semicolon should be inserted following “SEQ ID NO:1”.
In claim 28, “additional” should be added after “at least one”. Furthermore, the limitation of “the enzymes encoded by” should be removed or “encoded by” should be removed as the sequences are the enzymes.
In claim 29, “additional” should be added after “at least one”.
In claim 32 the comma should be replaced with “/”.
In claim 34, the “s” after composition should be removed.
Claim 40 is objected for the following informality: it is suggested that claim 40 be amended as follows: The biofilm degrading composition of claim 25, comprising the dextranase and the mutanase in a 5:1 ratio.
New Rejections
Claim Rejections - 35 USC § 112
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 28, 32 is 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.
Claim 28 is considered indefinite because it recites “enzymes encoded by SEQ ID Nos:2, 12, 14…26”, whereas those SEQ ID Nos correspond to amino acid sequences, and the phrase “encoded by” ordinarily refers to a nucleotide sequence, rendering the scope of the claim unclear. Claim 32 is rejected due to its dependence on claim 28 and not further clarifying this point of confusion.
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 1-26 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).
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.
Conclusion
No claims are allowed.
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