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 .
Claims 102-136 are pending.
Claims 1-101 are cancelled.
Claims 102-105, 110-136 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 106-109 are pending and examined on the merits.
Applicant’s remarks filed on 4/16/2026 in response to the Non-Final Rejection mailed on 2/5/2026 have been fully considered and are not deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Priority
Acknowledgement is made of this continuation application of Non-provisional Application No. 18/351,069, filed on 6/16/2020, which claims priority to national stage entry of PCR/EP2018/085339, filed on 12/17/2018, which claims foreign priority to PCRCN2017117174, filed on 12/19/2017. Copies of the foreign priority are located in the parent application s/n 16/954,367, filed on 6/16/2020.
Maintained Claim Rejections - 35 USC § 112 – Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 106-109 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention is maintained.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claims 106-109 are drawn to a method of creating a lysophospholipid in a lipid containing food matrix comprising adding to the lipid containing food matrix an isolated polypeptide comprising a phospholipase Al characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12. The structure of the phospholipase A1 is a large number of sequences.
In this case, the specification discloses the following representative structure phospholipase A1 as encompassed by the claims (i.e. SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16 ). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of phospholipase A1. The breadth of the claims encompass any phospholipase A1 through genetic modification of genes encoding proteins or post-translational modifications, etc. via any modification technique such as deletion, mutation, etc. for creating a lysophospholipid.
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Here, the disclosure fails to teach which phospholipase A1 out of the numerous possibilities for creating a lysophospholipid.
Accordingly, one of skill in the art would not accept the disclosure of phospholipase A1 comprising of the amino acid sequence of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16. as being representative of all phospholipase A1 as encompassed by the claims. As such, the specification, taken with the pre-existing knowledge in the art of phospholipase A1 fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph. It is noted that Applicant could overcome the rejection by incorporating the structural limitations of claim 109 into claim 106.
RESPONSE TO REMARKS: Beginning on p. 2 of Applicants’ remarks, Applicants in summary contend that claims 106-109 do not claim phospholipase Al enzymes generically. Rather, they are narrowly limited by multiple, interlocking constraints, including: a defined sn-1/sn-2 specificity ratio, a defined lysophospholipase/phospholipase activity ratio and/or NALPE/NAPE activity ratio; and in dependent claim 109, explicit structural limitation to enzymes having at least 80% identity to SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, or 16. Applicant contends that the Board's and Federal Circuit's framework for functional genus claims, the written description requirement is satisfied where the specification provides either (i) a representative number of species within the scope of the claimed genus and/or (ii) identifying characteristics-such as objective, assay-based criteria-that allow a person of ordinary skill in the art to visualize or recognize the members of the genus. Here, the specification does both. It discloses multiple representative phospholipase Al species (SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, and 16) and provides objective, measurable functional criteria (snl/sn2 specificity ratio and suppressed side-activity ratios) for determining whether a candidate enzyme falls within the claimed genus under the disclosed assays. Accordingly, the claims are not a result-only "research plan"; they are bounded by disclosed species and objective criteria that demonstrate possession of the claimed genus. Applicant contends that the written description requirement is satisfied because the specification demonstrates possession of the genus by disclosure of representative species and identifying characteristics sufficient for a skilled artisan to recognize members of the claimed genus.
The arguments are not persuasive. Examiner contends that the recitation ‘an isolated polypeptide comprising a phospholipase Al characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12’ are functional limitations, as opposed to structural limitations. Examiner contends that while Applicant has satisfied the functional requirement, the structural requirement has not been satisfied. Applicant’s assertion that the disclosure of multiple representative phospholipase Al species (SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, and 16) provides objective, measurable functional criteria (snl/sn2 specificity ratio and suppressed side-activity ratios) for determining whether a candidate enzyme falls within the claimed genus under the disclosed assays is not limited to just the stated SEQ ID Nos, as on page 2 of the instant application, Applicant states that ‘optionally, the phospholipase A1 is an enzyme comprising a protein sequence having … identity to SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, and 16.’ Examiner contends that Applicant’s use of the term ‘optionally’ provides further evidence that the stated SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, and 16 are not representatives of all the possible species of phospholipase A1. Furthermore, Examiner contends that Applicant’s reliance on dependent claim 109 which recites ‘wherein said phospholipase Al is an enzyme comprising a protein sequence having at least 80% sequence identity to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16’ fails to meet the written description requirement as claim 106 remains sufficiently broad. Examiner contends that each claim must be evaluated separately on their own. Supporting the Examiner’s position is MPEP 2163.II.1, which states “claim construction is an essential part of the examination process. Each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description. See, e.g., In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1319-1320, 97 USPQ2d 1737, 1750 (Fed. Cir. 2011) (stating that "[t]he construction of the claims [is] important to the written description analysis" and patent holder’s failure "to point to a genuine factual dispute over whether the specification disclosed" the claimed subject matter made summary judgment proper on that issue.); In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997).”
Therefore, Examiner contends that the reliance on a dependent claim (instant application claim 109) to satisfy the written description requirement is incorrect. In order to overcome the 112a written description rejection, it is recommended that Application amend claim 106 to add the recited species of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16. Adding said claim language along with the ‘at least 90% sequence identity’ would satisfy the written description requirement.
Applicant contends that the parent application issued as U.S. Patent No. 11,744,254 on claims directed to the same phospholipase Al enzymes characterized by the same functional parameters and sequence identities, and the parent Examiner found those enzymes "not ... found in the prior art, particularly, the phospholipase Al having the claimed parameters or having the claimed sequence identity." While allowance was based on patentability over the prior art, the Office's prior treatment of materially identical disclosure and materially identical enzyme definitions is at least strongly persuasive that the present specification conveys possession of the claimed enzymatic genus. Applicant contends that the present application's specification is identical in substance to the parent specification with respect to phospholipase Al structure, function, and sequence disclosure. There is no new claim language here that expands the enzyme genus beyond what was already found to satisfy @ 112(a) in the parent. Absent new evidence or a material change in claim scope, the Office cannot properly re-reject the same disclosure on a theory already resolved on the merits. The Examiner's "incorporate claim 109" suggestion underscores written description support The Office Action states that the § 112(a) rejection could be overcome by incorporating the structural limitations of claim 109 into claim 106. That suggestion itself confirms that the specification clearly supports phospholipase Al enzymes defined by the recited sequence identities. Because claim 109 already depends from claim 106, any perceived breadth concern is, at most, a claim-drafting preference -not a written-description defect. Accordingly, the § 112(a) rejection of claims 106-109 should be withdrawn.
The argument is not persuasive. Examiner contends that the patentability of a previously filed application does not mandate an automatic allowance based on the similarity of the claim language. Examiner contends that the patentability of an application is based on the thorough examination practices by the individual Patent Examiner. Examiner contends that the 112a written description rejection is not rejected on a theory already resolved on the merits. Examiner contends that the recitation ‘a method of creating a lysophospholipid in a lipid containing food matrix comprising adding to the lipid containing food matrix an isolated polypeptide comprising a phospholipase Al characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12’ is sufficiently broad as it encompasses a large number of phospholipase Al enzymes. Examiner contends that said recitation does not contain any structural limitations that would allow one of ordinary skill in the art to make and use the phospholipase A1 enzyme. Especially since it only requires 80% sequence identity, as recited in the instant application dependent claim 109, which encompasses a large number of sequences.
Maintained 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 rejection of claims 106-109 under 35 U.S.C. 103 as being unpatentable over Clausen et al (WO 98/26057, Date of Publication: 18 June 1998, cited on IDS dated 7/12/2023 and cited on PTO-892 dated 2/5/2026) {herein Clausen} in view of Wang et al (2015, BMC Genomics, cited on PTO-892 dated 2/5/2026) {herein Wang} is maintained.
Claims 106-109 are drawn to a method of creating a lysophospholipid in a lipid containing food matrix comprising adding to the lipid containing food matrix an isolated polypeptide comprising a phospholipase Al characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12.
With respect to claims 106, 108, Clausen teaches a method of adding phospholipases such as phospholipase A1 into bread dough as an additive to increase elasticity of the bread (page 2, lines 3-6; page 4, lines 6-11). Absent evidence otherwise, it is the Examiner’s position that bread dough is a food matrix. Clausen further teaches an isolated polypeptide having phospholipase activity and the corresponding cloned DNA sequence of the invention may be obtained from any microorganism, preferably a fungus (page 39, lines 21-24).
However, Clausen does not teach a phospholipase Al characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12 (claim 106). Clausen does not teach wherein the snl/sn2 specificity ratio is about 60/40, 70/30, 80/20, 90/10, 95/5 or 99/1 (claim 107). Clausen does not teach wherein said phospholipase Al is an enzyme comprising a protein sequence having at least 80% sequence identity to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16 (claim 109).
With respect to claims 106-107, 109, Wang teaches phospholipase A1 from Pestalotiopsis fici that is at least 80% identical to SEQ ID NO: 4 of the instant application (appendix A). Since the art teaches the structure of the phospholipase A1 (Pestalotiopsis fici natural product), it is the Examiners position that the phospholipase A1 (SEQ ID NO: 4) taught by Wang would inherently have an snl/sn2 specificity ratio of about 55/45 or greater; a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12 (instant application claim 106). Furthermore, a snl/sn2 specificity ratio about 60/40, 70/30, 80/20, 90/10, 95/5 or 99/ (instant application claim 107). MPEP 2112 recites ‘Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).’
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Clausen et al of a method of adding phospholipases such as phospholipase A1 from fungi into bread dough as an additive to increase elasticity of the bread (page 2, lines 3-6; page 4, lines 6-11) by combiing the teachings of Wang, because Wang teaches phospholipase A1 from Pestalotiopsis fici that is at least 80% identical to SEQ ID NO: 4 of the instant application (appendix A) and antimicrobial properties (page 2, column 1, para 2).
One of ordinary skill in the art would be motivated to either use the teachings of Clausen et al. by itself or combine the teachings of Wang because Wang provides the motivation for Clausen to utilize phospholipase A1 from Pestalotiopsis fici (instant application SEQ ID NO: 4) because said phospholipase A1 (natural product of Pestalotiopsis fici) is implicated as having antifungal effects against Aspergillus fumigatus (page 2, column 1, para 2). As such, utilization of said enzyme would likely reduce the occurrences of contamination of food sources by Aspergillus fumigatus. Additionally, said phospholipase A (instant application SEQ ID NO: 4) is being readily studied for its antibiotic, anticancer and agrichemical properties (page 1, column 2, para 1). One of ordinary skill in the art would have a reasonable expectation that substituting the phospholipase A1 taught by Clausen with the phospholipase A1 taught by Wang (instant application SEQ ID NO: 4) would result in dough with reduced contaminants as Wang teaches phospholipase A1 (natural product of Pestalotiopsis fici) is implicated as having antifungal properties (page 2, column 1, para 2). As such, utilizing said phospholipase would result in a reduction in costs associated with antimicrobial contamination of food sources and extend its shelf-life.
One of skill in the art would have a reasonable expectation of success to make and use the claimed lysophospholipid in a lipid containing food matrix because Clausen provides the basic method of making it. Reference of Wang provides the teachings of a phospholipase A1 from Pestalotiopsis fici that is at least 80% identical to SEQ ID NO: 4 of the instant application (appendix A). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 4 of Applicants’ remarks, Applicants in summary contend that the Office Action asserts that because Wang discloses a phospholipase Al sequence that is 100% identical to SEQ ID NO:4, the enzyme inherently possesses the claimed sn-1/sn-2 specificity and suppressed side activities. This inherency analysis is legally and factually flawed. Applicant contends that even assuming arguendo that Wang discloses a protein sequence matching SEQ ID NO:4, Wang is silent as to the enzyme preparation, maturation/processing state, and assay conditions under which the claimed functional ratios are determined. Applicant contends that the instant claims require specific quantitative activity ratios, and the record contains no evidence that the Wang disclosure necessarily and inevitably yields those ratios under the claimed assays. Applicant contends that the Office Action provides no experimental evidence, scientific rationale, or factual predicate establishing that the Wang enzyme inherently exhibits Applicant's claimed functional parameters.
The arguments are not persuasive. Examiner contends that since Wang teaches the enzyme of the claimed invention with 100% sequence identity to SEQ ID NO: 4, said enzyme would inherently would the same functional characterstics of the claimed enzyme. Especially since Wang teaches a higher presence similarity that the instant application of a sequence identity of 80%. Furthermore, Examiner contends that Applicant has not disclosed any mutations and/or substitutions that would make it obvious to one of ordinary skill in the art that the claimed phospholipase A1 is structurally different from the phospholipase A1 taught by Wang. Examiner contends that although Wang is silent to the enzyme preparation, maturation/processing state, and assay conditions under the claimed functional ratios, it does not negate the fact that Wang teaches the enzyme with 100% sequence identity. Examiner contends that one of ordinary skill in the art would reasonably conclude that since the enzyme taught by Wang (SEQ ID NO: 4) has 100% sequence identity to the claimed invention, then it would inherently have the same characteristics. Examiner contends that Wang provides the motivation for Clausen to utilize phospholipase A1 from Pestalotiopsis fici (instant application SEQ ID NO: 4) because said phospholipase A1 (natural product of Pestalotiopsis fici) is implicated as having antifungal effects against Aspergillus fumigatus (page 2, column 1, para 2). As such, utilization of said enzyme would likely reduce the occurrences of contamination of food sources by Aspergillus fumigatus. Additionally, said phospholipase A (instant application SEQ ID NO: 4) is being readily studied for its antibiotic, anticancer and agrichemical properties (page 1, column 2, para 1). Examiner welcomes a Declaration providing evidence that the phospholipase A1 (100% sequence identity to SEQ ID NO: 4 of the instant application claim 109) taught by Wang is not the same as the phospholipase A1 of the instant application.
Applicant contends that the office's reliance on inherency also fails for an independent reason: when invoking inherency, the Office must provide a basis in fact and/or technical reasoning showing that the allegedly inherent characteristic necessarily flows from the applied disclosure, not merely that it could arise under some conditions. Only after that predicate is established does any burden shift become relevant. Here, because Wang does not disclose the claimed assays or conditions and provides no technical rationale establishing that the claimed ratios necessarily result, the Office has not met its initial burden.
This argument is not persuasive. Examiner contends that the only claimed assays or conditions of the instant application, in summary, is adding an isolated phospholipase A1 to a lipid containing food matrix, wherein the lipid containing food matrix is dough for sweet bakery goods (instant application claims 106, 108) which is similar to the teachings of Clausen whom teaches a method of adding phospholipases such as phospholipase A1 into bread dough to increase the elasticity of the bread (page 2, lines 3-6; page 4, lines 6-11), which are the claimed assay or conditions. Examiner contends that the recitation having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12 are characteristics of the enzyme, therefore do not require any active steps.
Applicant contends that Wang is non-analogous because it is neither (i) within the same field of endeavor as the claimed invention (enzymatic modification of phospholipids in food matrices) nor (ii) reasonably pertinent to the problem addressed by the inventors (selective lysophospholipid formation while suppressing side activities in lipid-containing food matrices). Accordingly, Wang cannot supply a proper motivation to combine with Clausen for the claimed purpose. The proposed motivation to combine Clausen and Wang rests on Wang's teaching of antimicrobial or antifungal properties.
The argument is not persuasive. Examiner contends that the motivation to combine art need not be the same as the instant application. Supporting the Examiner’s position is MPEP 2144.IV which states “the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).”
Furthermore, “in In re Lintner, the claimed invention was a laundry composition consisting essentially of a dispersant, cationic fabric softener, sugar, sequestering phosphate, and brightener in specified proportions. The claims were rejected over the combination of a primary reference which taught all the claim limitations except for the presence of sugar, and secondary references which taught the addition of sugar as a filler or weighting agent in compositions containing cationic fabric softeners. Appellant argued that in the claimed invention, the sugar is responsible for the compatibility of the cationic softener with the other detergent components. The court sustained the rejection, stating "The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be [sic, would have been] prima facie obvious from the purpose disclosed in the references." 173 USPQ at 562.”
Maintained 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.
The rejection of claims 106-109 on the ground of nonstatutory double patenting as being unpatentable over claims 102-103, 116 of U.S. Patent No. US 11,744,254 B2, of which is commonly owned, has a common inventor and was filed earlier than the instant application. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a method of a food composition comprised of phospholipase A1 derived from a fungus.
The instant application claims 106, 108 are not patentably distinct from claim 1 of ‘254 because claim 1 of ‘254 recites ‘a method of making a dough, said method comprising admixing a dough component selected from the group consisting of flour, salt, water, sugar, fat, lecithin, oil. emulsifier and yeast with an isolated polypeptide comprising a phospholipase 1 characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase A1 has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12,’ which is not patentably distinct from the instant application claims 106, 108.
The instant application claim 107 is not patentably distinct from claim 2 of ‘254 because claim 2 of ‘254 recites ‘the method of claim 1 wherein the sn1/sn2 specificity ratio is about 60/40, 70/30, 80/20, 90/10, 95/5 or 99/1,’ which is not patentably distinct from the instant application claim 107.
The instant application claim 109, is not patentably distinct from claim 15 of ‘254 because claim 15 of ‘254 recites ‘the method of claim 14 wherein said phospholipase A1 is an enzyme comprising a protein sequence having at least 80% sequence identity to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID 60 NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16,’ which is not patentably distinct from the instant application claim 109.
RESPONSE TO REMARKS: Beginning on p. 6 of Applicants’ remarks, Applicants in summary contend that obviousness-type double patenting applies only where the pending claims are not
patentably distinct from the claims of the reference patent. Here, claims 106-109 are directed to a different method, performed in a different operative context, and achieving a different outcome than the method claimed in the '254 patent.
The argument is not persuasive. Examiner contends that claim 1 of ‘254 recites ‘a method of making a dough, said method comprising admixing a dough component selected from the group consisting of flour, salt, water, sugar, fat, lecithin, oil, emulsifier and yeast with an isolated polypeptide comprising a phospholipase 1 characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase A1 has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12,’ which is not patentably distinct from the instant application claims 106, 108 which recites, ‘a method of creating a lysophospholipid in a lipid containing food matrix comprising adding to the lipid containing food matrix an isolated polypeptide comprising a phospholipase Al characterized by having an snl/sn2 specificity ratio of about 55/45 or greater wherein said phospholipase Al has a lysophospholipase/phospholipase activity ratio of less than 0.02 and/or a NALPE/NAPE activity ratio of less than 0.12’ (instant application claim 106), wherein the food matrix is selected from the group consisting of eggs and food products containing eggs, dough for sweet bakery goods, processed meat, milk based products, and vegetable oil (instant application claim 108).
Furthermore, Examiner contends that claim 2 of ‘254 is not patentably distinct from the instant application claim 107, because both claims recite the functional characteristic of the phospholipase A1 enzyme having a sn1/sn2 specificity ratio of about 60/40, 70/30, 80/20, 90/10, 95/5 or 99/1.
Additionally, Examiner contends that ‘254 is not patentably distinct from the instant application claim 109, because both claims recite a ‘phospholipase A1 an enzyme comprising a protein sequence having at least 80% sequence identity to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10 SEQ ID 60 NO: 12, SEQ ID NO: 14 or SEQ ID NO: 16.’
Conclusion
Status of claims
Claims 1 to 101 are cancelled.
Claims 102-105, 110-136 are withdrawn pursuant to 37 CFR 1.142(b).
Claims 106-109 are pending.
Claims 106-109 are rejected.
No claims are in condition for allowance.
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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656
Appendix A
Instant Application SEQ ID NO: 4 vs Wang et al
Query Match 100.0%; Score 858; Length 180;
Best Local Similarity 100.0%;
Matches 162; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VPVADKRQDDVEAVTDEILFDITLPEFTTRRNAEDPSYLDWTSDGCTDSPDNPLGFPYEP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 19 VPVADKRQDDVEAVTDEILFDITLPEFTTRRNAEDPSYLDWTSDGCTDSPDNPLGFPYEP 78
Qy 61 ACNRHDFGYTNYREQSRFTVSAKASIDSNFKDDLYYQCEVNGSFESICEALADVYYAAVV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 ACNRHDFGYTNYREQSRFTVSAKASIDSNFKDDLYYQCEVNGSFESICEALADVYYAAVV 138
Qy 121 EFGGDDATPGKRSSLYEEKLAIYNQLVAEAVAKGELVLPETA 162
||||||||||||||||||||||||||||||||||||||||||
Db 139 EFGGDDATPGKRSSLYEEKLAIYNQLVAEAVAKGELVLPETA 180
Prosecution Insights