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
Status of the Claims
Claims 1-17 are pending in this application.
Claims 1-17 are presently under consideration.
Duplicate claims
Applicant is advised that should claim 1 be found allowable, claims 4, 7 and 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
In the instant case, claims 4, 7 and 10 relate to the same peptide of claim 1. The inherent properties of the peptide do not further limit said peptide. Therefore, claims 4, 7 and 10 are duplicates of claim 1.
Claim Rejections - 35 USC § 112
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, 6, 9, 12-13 and 17 are 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. Claims 3, 6, 9 and 12-13 are drawn to an intended use of the composition of claims 2, 5 and 11. Thus, they do not further limit the subject matter of claims 2 and 5. Claim 17 is drawn to inherent properties of the graft material of claim 14. Thus, it does not further limit the subject matter of claim 14. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jong-pyeong (WO2020036242A1).
With respect to claims 1, 4, 7 and 10, Jong-pyeong teaches the antimicrobial and anti-inflammatory peptide GKCSTRGRKSSRRKK (SEQ ID NO: 3 on page 3; abstract; passim), which corresponds to instantly claimed SEQ ID NO: 1.
With respect to claims 2-3, 5-6, 8-9 and 11-13, Jong-pyeong teaches a pharmaceutical composition comprising the peptide (title; abstract; passim). Please note that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02).
In the instant case, the peptide’s inherent properties (anti-inflammatory, antibacterial, cell-penetrating, and tissue-penetrating) do not add any further structural differences. Similarly, the intended use of the claimed pharmaceutical compositions (i.e. the claimed treatment) do not add any further structural differences.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jong-pyeong (WO2020036242A1) in view of Bishop et al. (US 2010/0022750).
The teachings of Jong-pyeong with respect to claims 1-13 have been discussed above.
Jong-pyeong do not teach a graft comprising the peptide.
With respect to claims 14-15, Jong-pyeong teaches that “[The composition of the present invention is a pharmaceutically acceptable carrier may include excipients (e.g., starch, lactose, calcium carbonate, calcium phosphate, etc.), binders (e.g., starch, gum arabic, carboxymethylcellulose, hydroxymethylcellulose, Crystalline cellulose, etc.), lubricants (e.g., magnesium stearate, talc, etc.), disintegrating agents (e.g., carboxymethylcellulose calcium, talc synthetic aluminum silicate, etc.), diluents (e.g., water, vegetable oils, etc.) Or mixtures of two or more thereof” (page 3, 7th para), and further teaches that the peptide is used for the treatment of peri-implantitis (page 3, 1st para; passim). Therefore, since peri-implantitis is an infection that destroys bone around a dental implant, one of ordinary skill in the art would have been motivated to make a graft material comprising the peptide, and/or bone minerals such as calcium carbonate, calcium phosphate, and/or synthetic polymers such as carboxymethylcellulose, hydroxymethylcellulose.
The skilled artisan would have reasonably expected the graft comprising the peptide to help rebuilding the lost bone while exerting its anti-inflammatory and anti-bacterial action.
With respect to claim 16, Jong-pyeong teaches 10-5 to 10-3 part by weight of the peptide (claim 2). Furthermore, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum amount by normal optimization procedures known in the pharmaceutical art.
With respect to claim 17, the graft material’s inherent properties (antibiotic; anti-inflammatory, or periodontal tissue regeneration abilities) do not add any further structural differences with the graft material of claim 14. Furthermore, Jong-pyeong teaches that the peptide has antibacterial and anti-inflammatory properties (title; abstract). Therefore, one of ordinary skill I the art would have reasonably expected a graft comprising the peptide to maintain said properties.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jong-pyeong (KR101320472B1) in view of Bishop et al. (US 2010/0022750).
With respect to claims 1, 4, 7 and 10, Jong-pyeong teaches the anti-bacterial and anti-inflammatory peptide GKCSTRGRKCCRRKK (SEQ ID NO: 2 on page 2).
Jong-pyeong does not teach substituting the two cysteine residues with serine residues.
Bishop et al. teach “[T]he sequence of Peptide-I may be denoted as (RGRKSSRRKK). This ten-residue peptide is based on the C-terminal region of hBD-3. In Peptide-I, serine residues may be used in place of cysteine residues present in the parent hBD-3. Reportedly, Peptide-I is known to demonstrate antimicrobial potency at concentrations as low as 4 μg/ml” (para [0101]; claim 3).
Given that the peptide of Jong-pyeong comprises the peptide of Bishop, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success to modify the peptide of Jong-pyeong by substituting the two cysteine residues with serine residues.
The skilled artisan would have had a reasonable expectation of success because Bishop et al. teach that the peptide in which these specific cysteine residues were substituted with serine resides, maintain anti-microbial activity.
With respect to claims 2-3, 5-6, 8-9 and 11-13, Jong-pyeong teaches a pharmaceutical composition comprising the peptide (title; abstract; passim). Please note that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02).
In the instant case, the peptide’s inherent properties (anti-inflammatory, antibacterial, cell-penetrating, and tissue-penetrating) do not add any further structural differences. Similarly, the intended use of the claimed pharmaceutical compositions (i.e. the claimed treatment) do not add any further structural differences.
With respect to claims 14-15, Jong-pyeong teaches that “[P]harmaceutically acceptable carriers of the compositions for treating dental infections of the present invention include excipients such as starch, lactose, calcium carbonate, calcium phosphate, etc., and binders such as starch, gum arabic, carboxymethylcellulose, hydroxymethylcellulose, crystalline cellulose, and the like (page 3, 7th para), and further teaches that the peptide is used for the treatment of peri-implantitis. Therefore, since peri-implantitis is an infection that destroys bone around a dental implant, one of ordinary skill in the art would have been motivated to make a graft material comprising the peptide, and/or bone minerals such as calcium carbonate, calcium phosphate, and/or synthetic polymers such as carboxymethylcellulose, hydroxymethylcellulose.
The skilled artisan would have reasonably expected the graft comprising the peptide to help rebuilding the lost bone while exerting its anti-inflammatory and anti-bacterial action.
With respect to claim 16, Jong-pyeong teaches 10-3 to 1 part by weight of the peptide (page 3, 5th para). Furthermore, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum amount by normal optimization procedures known in the pharmaceutical art.
With respect to claim 17, the graft material’s inherent properties (antibiotic; anti-inflammatory, or periodontal tissue regeneration abilities) do not add any further structural differences with the graft material of claim 14. Furthermore, Jong-pyeong teaches that the peptide has antibacterial and anti-inflammatory properties (title; abstract). Therefore, one of ordinary skill I the art would have reasonably expected a graft comprising the peptide to maintain said properties.
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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-8 of copending Application No. 18/262543 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same peptide.
With respect to claims 1, 4, 7 and 10, ‘543 teaches a method for treating fibrosis comprising administering a peptide consisting of SEQ ID NO: 2 (i.e. GKCSTRGRKSSRRKK) (claim 1), which corresponds to instantly claimed SEQ ID NO: 1.
With respect to claims 2-3, 5-6, 8-9 and 11-13, ‘543 teaches a pharmaceutical composition comprising the peptide (claim 6). Please note that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02).
In the instant case, the peptide’s inherent properties (anti-inflammatory, antibacterial, cell-penetrating, and tissue-penetrating) do not add any further structural differences. Similarly, the intended use of the claimed pharmaceutical compositions (i.e. the claimed treatment) do not add any further structural differences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/836830 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same peptide.
With respect to claims 1, 4, 7 and 10, ‘830 teaches a bioabsorbable guided tissue regeneration composition comprising SEQ ID NO: 1 (i.e. GKCSTRGRKSSRRKK) (claim 8), which corresponds to instantly claimed SEQ ID NO: 1.
With respect to claims 2-3, 5-6, 8-9 and 11-13, the composition of ‘830 is a pharmaceutical composition. Furthermore, it is noted that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02).
In the instant case, the peptide’s inherent properties (anti-inflammatory, antibacterial, cell-penetrating, and tissue-penetrating) do not add any further structural differences. Similarly, the intended use of the claimed pharmaceutical compositions (i.e. the claimed treatment) do not add any further structural differences.
With respect to claim 14, ‘830 teaches a graft material comprising the peptide (claims 6-8).
With respect to claim 15, ‘830 teaches that the graft material comprises collagen (claim 6).
With respect to claim 16, ‘830 teaches that the graft material includes 10-4 to 0.5 parts by weight of the peptide (claim 9).
With respect to claim 17, ‘830 teaches that the peptide has antibacterial activity, anti-inflammatory activity, and cell-penetrating properties (claims 7 and 23).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
Prosecution Insights