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 .
Election/Restrictions
In the reply filed 10/23/25, Applicant amended claims 1-6 and 14-16 from composition claims to method claims.
Applicant’s election with traverse of Group II, drawn to a method of removing LPS, claimed in claims 1-6 and 14-16 in the reply filed on 10/23/25 is acknowledged. Election was made of FP12 (peptide of part e in claim 2).
The traversal is on the ground(s) that the subject matter of Group I is directed to a physical embodiment using the same peptide of claim 1-16 and 14-16, directed to removing LPS. This is not found persuasive because the application is a 371 case and as indicated in the Restriction requirement and in the 102 rejection below, the technical feature is not a special technical feature in view of the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-12, 14-16 are pending.
Claims 1-6 and 14-16 are under consideration.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1: the sequence K-L-G-V-E-A-K-R-Y-L-D requires a sequence identifier. Claim 1 should be amended to “…K-L-G-V-E-A-K-R-Y-L-D (SEQ ID NO: 1)…”.
Claim 2: the sequence of a-i require a sequence identifier since each amino acid is defined. For example, the peptide of part a is SEQ ID NO: 2. Each sequence requires a sequence identifier.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1, 3-6 and 16 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that 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, 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. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 1 is drawn to a method of removing LPS comprising brining a sample in contact with a polypeptide represented by the sequence of the general formula and isolated the combination of the polypeptide represented by the general formula and LPS from the sample:
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The USPTO provides claim terms with broadest reasonable interpretation in light of the specification.
Assessment of whether species are support in the original specification
12 embodiment of the invention of claims were reduced to practice at the time of filing. Applicants disclosed:
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Please note that the amino acid sequence of 6 and 8 are the same, except SEQ ID NO: 8 is all D amino acid. The amino acid sequence of SEQ ID NO: 7, 9 and 13 are the same except SEQ ID NO: 9 is all D amino acids and SEQ ID NO: 13 is all D amino acids and acetylated.
There was no disclosure of other peptide sequences that meet the limitations of the general formula that able to bind LPS.
In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of SEQ ID NO: 2-13 at the time the invention was filed.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, the disclosure of SEQ ID NOs:2-13 are not representative of the genus. The disclosure of the sequences are not representative of the entire genus encompassed by the general formula that is capable of removing LPS.
With the aid of a computer, one of ordinary skill in the art could identify all of the peptides with that meet the structural limitations of the general formula. However, there is no teaching regarding which sequences would result in a peptide that is capable of removing LPS.
Therefore, disclosure of SEQ ID NO: 2-13 are not representative of the genus.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied 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. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of a peptide leads to the claimed functions of removing LPS.
For all of the reasons presented above, one of ordinary skill in the art would not know which of the countless peptides that meet the structural requirements of the claims would also be able to specifically remove LPS. This is an issue of written description. The specification does not make clear which peptides are in the genus and which are not because it does not describe the physical basis for the claimed activity. In other words, the specification does not describe which proteins to make.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession of SEQ ID NO: 2-13.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 depends from instant claim 1, which recites and requires a “polypeptide” having the general structure of
Ln-X1-L-X2-V-X3-X4-X5-R-X6-L-X7
wherein each position of the structure is explicitly defined as an amino acid of leucine, valine, arginine, lysine, glycine, glutamic acid, alanine, tyrosine, tryptophan, or aspartic acid (instant claim 1). However, claim 3 claims the polypeptide is a peptidomimetic, comprising an L-type polypeptide, a D-type polypeptide or a peptoid or a non-natural amino acids. Claim 1 does not identify that any position may be other than L-amino acids of leucine, valine, arginine, lysine, glycine, glutamic acid, alanine, tyrosine, tryptophan, or aspartic acid. Accordingly, claim 3 is rejected for failing to include all the limitations of the claim upon which it depends.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 14-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Park et al. (US2022/0144892, priority date: 2/26/2020).
The applied reference has a common inventor (In Duk Jung) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Park et al. teach peptides having antimicrobial activity, preventing or treating sepsis (Abstract). Park et al. teach that sepsis is an inflammatory response caused by excessive activation of the immune system by LPS [0003]. Park et al. teach and claim the polypeptide has the ability to bind LPS of gram negative bacteria ([0108, 0283,0335] and claim 6). Park et al. teach Example 1, wherein the measurement of LPS binding was measured [0352]. In particular, Park et al. teach FP3, FP5, FP6, FP9, allD_FP12-NH2, allD_FP13-NH2, allD_FP-13-9a, allD_FP-13-9w, allD_FP-13-9k, and allD_FP13-NH2 (AcOH) [0352], please note that these peptides are identical to SEQ ID NO: 2-13 in the instant specification and meet the limitations of general formula of claim 1 and a-i in claim 2. Example 1 discloses LPS and the peptides were brought into contact and the binding was analyzed. In particular, Park et al. teach that the when the measurement was completed, analysis is performed and the kD values of LPS and the peptide were calculated [0354-0355], meeting the limitations of S1 and S2 since the binding analysis and Kd determination necessarily isolates the polypeptide-LPS complex by selectively measuring the bound species apart from the unbound. Please note that the peptides above are not K-L-G-V-E-A-K-R-Y-L-D. SEQ ID NO: 12 from Park et al., is identical to instantly claimed claim 2 (i)(elected species):
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With respect to claim 3, SEQ ID NO: 12 from Park et al. is a D-type polypeptide.
With respect to claims 4 and 5, SEQ ID NO: 12 from Park et al. is amidated.
With respect to claim 6, Park et al. teach acetate salt substitutes [0114-0115].
With respect to claim 16, Park et al. teach the peptides removed endotoxins derived from bacteria (Abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US2022/0144892, priority date: 2/26/2020) in view of G-Biosciences (Trypsin recombinant, proteomics grade, June 28, 2011).
Park et al. teach the peptides in combination with E. coli and trypsin (Table 5). E. coli comprises LPS. Trypsin is a protein.
Park et al. does not specifically teach that trypsin is a recombinant protein. However, the teachings of G-Biosciences cure this deficiency.
G-Biosciences teaches recombinant trypsin genetically engineering and expressed in E. coli and purified by high pressure liquid chromatography. G-Biosciences teaches the trypsin is an animal free source , so its virus free with no contaminating proteases.
It would have been obvious to a person of ordinary skill in the art to use the recombinant trypsin of G-biosciences because it is virus free and has no contaminating proteases. There is a reasonable expectation of success given that recombinant enzyme is commercially available and routinely used in the art.
Claims 1-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US2022/0144892, priority date: 2/26/2020) in view of Beckman Coulter (https://www.beckman.com/resources/reading-material/whitepapers/centrifugation-workflow-solution-for-protein-purification-and-protein-aggregation-quantification Nov. 14, 2017).
The teachings of Park et al. are presented above in detail. The reference does not teach the combination is isolated through centrifugation. However, the teachings of Beckman Coulter cures this deficiency.
Beckman Coulter teaches that centrifugation is a powerful tool for workflows to isolate and characterize protein products. Beckman Coulter teaches that a centrifugation based workflow can be highly effective because it systemically addresses the need to remove aggregates by employing increasing g-force and density gradients to separate particles based on mass and density.
It would have been obvious to a person of ordinary skill in the art to isolate the combination of the peptide and LPS via centrifugation because it is a powerful tool to isolate protein products that is routine in the art. There is a reasonable expectation of success given that centrifugation is routine in methods of purification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 14-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,371,453. Although the claims at issue are not identical, they are not patentably distinct from each other. The USPN claims the same general formula as instantly claimed, wherein the polypeptide is alkylated, PEGylated or amidated, wherein an amine group is added to the C-terminus, an acetate salt (claims 1-5). The USPN claims the polypeptides for treating gram negative and positive bacteria and sepsis (claims 6-15). The USPN states that the polypeptides have binding ability for the LPS of gram negative bacteria. Administering the same peptides for the treatment of gram negative bacteria that comprise LPS would necessarily result in removing the LPS. Furthermore, it would be obvious to isolate the LPS and polypeptides in order to remove the endotoxin. There is a reasonable expectation of success given that the peptides bind to LPS.
Claims 1-6 and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/042,815 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application claims the polypeptides that are identical to the general formula instantly claimed for preventing, ameliorating or treating AD dementia, wherein the polypeptide is an L-form, D-form, peptidomimetic, peptoid or non natural amino acid, wherein the polypeptide is alkylated, PEGylated or amidated, wherein an amine group is added to the C-terminus, wherein the polypeptide or salt substitute suppresses LPS mediated cytokine production. The instant specification discloses that the peptides bind well with LPS would be effective for treatment of AD dementia [0199]. Administering the same peptides for the treatment of AD dementia and suppressing LPS mediated cytokine production would necessarily result in removing the LPS. Furthermore, it would be obvious to isolate the LPS and polypeptides in order to remove the LPS. There is a reasonable expectation of success given that the peptides bind to LPS.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TARA L MARTINEZ/Examiner, Art Unit 1654