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 .
Applicants’ amendment to the claims filed on 1/8/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 102-136 are pending.
Claims 1-101 are cancelled.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 1/8/2026 is acknowledged.
Claims 1-101 were cancelled by prior amendment.
Claims 102-105, 110-136 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 106-109 are pending and examined on the merits.
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.
It is noted, however, that applicant has not filed a certified copy of the English translation as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/12/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 7/12/2023 and 10/4/2023 are acknowledged and accepted by the examiner.
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.
Claims 106-109 are rejected 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.
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.
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.
Claims 106-109 are rejected 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 Examiner cited) {herein Clausen} in view of Wang et al (2015, BMC Genomics, Examiner cited) {herein Wang}.
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.
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 106-109 are rejected 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.
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.
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.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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