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 .
Claim Status
Claims 1-21 are pending. Claims 4 and 13-21 are withdrawn. Claims 1-3 and 5-12 are presently considered.
Election/Restrictions
Applicant's election with traverse of Group I (product claims 1-12) and the elected species of Example 1 and SEQ ID NO: 1 in the reply filed on 2/25/2026 is acknowledged. The traversal is on the grounds that US’614 does not teach the claimed sequences (see, e.g., Reply filed 2/25/2026 at 6 at 2nd ¶, alleging that the requirement is traversed). This is not found persuasive because the allegation is conclusory in nature and fails to identify with specificity how the instant claims avoid the prior art identified by the Examiner (see Requirement mailed 11/25/2026 at 6 at 3rd to 4th ¶¶, explaining how US’614 breaks unity of invention, specifically by the disclosure of SEQ ID NO: 56).
The requirement is still deemed proper and is therefore made FINAL.
The originally elected species is understood to be the peptide of Example 1 as described at pages 53-60 and Figures 6A-6G, having the structure of SEQ ID NO: 1. SEQ ID NO: 1 is understood to be HRKKRRQRRITRKKTFKEVA.
The originally elected species is understood to read upon: instant claims 1-3 because SEQ ID NO: 1 comprises KTFK; claim 5 because SEQ ID NO: 1 is explicitly recited; and claims 11-12. The elected species is understood to not read upon claim 4 because (i) the elected species reads upon claim 5, which depends from claim 1, and SEQ ID NO: 1 is between 4 and 30 amino acids in length, which suggests SEQ ID NO: 1 lacks an “from about 1-26 additional amino acids” as required by claim 4; (ii) the elected species does not comprise a sequence at Table 1 of the Specification; and (iii) Applicant failed to expressly identify any structure of claim 1 that satisfied the requirements of claim 4 (see, e.g., Requirement mailed 11/25/2025 at 4 at lines 3-5). In addition, it is unclear if or how the originally elected species reads upon claims 6-10. For purposes of examination in view of the prior art, it is reasonably assumed that claims 6-10 read upon at least a structure consisting of SEQ ID NO:1.
Following extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species of
TRKKTFKEVANAVKISASLMGT
which was subsequently deemed anticipated in view of the prior art. Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claims 13-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 2/25/2026.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 2/25/2026.
Claims 1-3 and 5-12 are presently considered.
Priority
The priority claim to US Provisional 63/108,157 as filed 10/30/2020 is acknowledged.
Information Disclosure Statement
The IDS filed 1/15/2025 is acknowledged and presently considered.
Applicant should note that one or more documents disclosed on the IDS form submitted on 1/15/2025 were not considered since they did not conform to 37 CFR 1.98(b) by providing a proper date, as 37 CFR 1.98(b) requires that each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. See MPEP 609.04(a). Here, the earliest priority claim is to US Provisional 63/108,157 as filed 10/30/2020; therefore, all documents published in 2019 or later must be accompanied by both month and date of publication.
References that were not considered have been indicated by strike-though on the attached IDS forms. Although not considered, these documents have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement, or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope and presently recites:
Claim 1. An isolated, synthetic peptide comprising from about 4 to 30 amino acids, wherein the peptide binds to Protein Kinase C (PKC) in vitro or in vivo.
Applicable claim interpretations are discussed below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
The range of “from about 4 to 30 amino acids” is understood to include 4 to 33 amino acids (see, e.g., Spec. filed 4/28/2023 at 11 at lines 30-31, defining “about” as ±10%).
The functional limitation of “wherein the peptide binds to Protein Kinase C (PKC) in vitro or in vivo” is understood to be fully satisfied by any compound comprising the tetramer consensus sequence of SEQ ID NO: 5 (i.e., XSXR, XSXK, XTXR, or XTXK, wherein each X is independently any amino acid; see instant claim 2) or the tetramer of SEQ ID NO: 6 (i.e., KTFK; see instant claim 3). This is reasonable in view of the disclosure, which identifies SEQ ID NO: 5 as the minimal consensus sequence (see, e.g., Spec. filed 4/28/2023 at 3 at lines 25-31).
Additional claim interpretations are discussed below.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show details as described in the specification because the drawings are illegible (see, e.g., Fig. 5F and 6D). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 9 attempts to define and claim a genus of structures by reciting a functional limitation that Applicant hopes and desires, namely “wherein the peptide binds to Protein Kinase C (PKC) in vitro or in vivo”, and at claim 9 reciting “wherein the PKC is PKCα”. This functional limitation does not correspond to an unambiguous structure of record, commensurate in scope with the claims. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of a function or results to be achieved by the claimed peptides rather than a description of the structures actually capable of achieving the desired functions. The specification states that “
In particular, disclosed is an isolated, synthetic peptide having about 4 to 30 amino acids, and which can bind to or be bound by to Protein Kinase C (PKC), either in vitro or in vivo. In some embodiments, the peptide minimally includes a Protein Kinase C consensus binding sequence, such as X-S/T-X-R/K (SEQ ID NO:5), wherein X is any amino acid.
Accordingly, the functional limitation of claims 1 and 9 are not defined, but rather exemplified at claim 2 by reference to a minimal consensus structure “such as” the genus of “X-S/T-X-R/K (SEQ ID NO: 5), wherein X is any amino acid” (see, e.g., Spec. filed 4/28/2023 at 3 at lines 25-31). Accordingly, it is unclear what other consensus structures, other than instant SEQ ID NO: 5, are potentially included by the scope of instant claims 1 and 9. Accordingly, the functional limitation of claims 1 and 9 render the claims indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what compounds do or do not infringe upon the scope of instant claim 1 other than sequences consisting of or comprising a sequence within the scope of instant SEQ ID NO: 5. Notably, the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, because it is unclear what compounds do or do not satisfy the functional limitations of claim 1, and an artisan would be unable to identify infringing from non-infringing compounds, claim 1 is rejected as indefinite.
Claim 6 is indefinite because it recites a product and a process of using the product within the same claim (i.e., “the peptide is further phosphorylated…. the peptide is phosphorylated at....”) (see, e.g., MPEP § 2173.05(p)(II)). Accordingly, it is unclear if infringement occurs before, during, or after the completion of the active method step, and therefore the claim is indefinite. For purposes of applying prior art in view of 35 USC §§ 102 or 103, claim 6 is reasonably understood to be rejected by any prior art sequence comprising any sequence of SEQ ID NO: 5 and having less than 33 amino acid residues.
Claims 7-8 and 10 recite functional limitations presumably further limiting the scope of instant claim 1, but the limitations fail to correspond to any structure/function relationship of record commensurate in scope with the claims. Accordingly, the functional limitations at claims 7-8 and 10 attempt to capture an unknown genus of unknown numbers of unknown structures of peptides capable of achieving an outcome or result Applicant hopes and desires to achieve, but such limitations fail to meaningfully define metes and bounds of structures permitting an artisan to actually avoid infringement of the claim scope. Accordingly, the functional limitation of claims 7-8 and 10 render the claims indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what compounds do or do not infringe upon the scope of instant claims 7-8 and 10 other than sequences consisting of or comprising a sequence within the scope of instant SEQ ID NO: 5, Notably, the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, because it is unclear what compounds do or do not satisfy the functional limitations of claims 7-8 and 10, and because an artisan would be unable to reasonably identify and distinguish infringing from non-infringing compounds within the scope of the claims, claims 7-8 and 10 are rejected as indefinite. In addition, close prior art exists as evidenced by the anticipatory rejections set forth on record below. For purposes of applying prior art in view of 35 USC §§ 102 or 103, claims 7-8 and 10 are reasonably understood to be rejected by any prior art sequence comprising any sequence of SEQ ID NO: 5 and having less than 33 amino acid residues.
Accordingly, claims 2-3 and 5-12 depend directly or indirectly from an indefinite base claim and fail to reconcile the indefiniteness of the base claim. Accordingly, these claims are rejected for reasons applied to the claim(s) upon which they depend.
Claims 1-3 and 5-12 are rejected.
Claim Rejections - 35 USC § 112(a)
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 and 5-12 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.
Brief Statement of the Issue(s)
The claims are directed to a genus of unknown size comprising peptides of unknown structures, wherein the claimed structures are defined by recitations of functional limitations pertaining to results that Applicant hopes and desires that the compounds may achieve, but the functional limitations fail to meaningfully correspond to a structure/function relationship commensurate in scope with the instant claims.
Claim Scope
Claims 1 and 6-10 are representative of the pending claims scope and recite products defined at least in part using functional limitations. It is unclear if the claim scope reads upon less than ten structures, or potentially trillions of structures (e.g., 2030 different sequences).
The applicable claim interpretations have been set forth above and the functional limitations have been addressed under 35 USC 112(b) above. Those discussions are incorporated herein.
It is unclear if the claim scope encompass trillions of species or perhaps only a few in view of the functional limitations set forth in the claim(s). Accordingly, the claim scope reasonably appears to be vast and highly varied.
Actual Reduction to Practice
The specification only unambiguously tests and discloses one working example of the claimed genus of peptides having about 4 to 30 amino acids in length, namely SEQ ID NO: 1 (see, e.g., Spec. filed 4/28/2023 at page 53 at lines 1-20).
Zero examples of any species within the scope of claim 1 having 4, 5, 6, 7, 8, 9, 10, etc. amino acids in length were reduced to practice (see instant claim 1).
Zero examples of any cyclic peptide species within the scope of claim 1 were reduced to practice (see, e.g., Spec. filed 4/28/2023 at pages 22-23 at bridging ¶).
Zero examples of any glycosylated, amidated, acetylated, acylated, alkylated, lipidated, PEGylated…. peptide species within the scope of claim 1 were reduced to practice (see, e.g., Spec. filed 4/28/2023 at pages 22 at lines 3-12).
Zero examples of any peptides containing D-amino acids were reduced to practice (see, e.g., Spec. filed 4/28/2023 at pages 21-22 at bridging ¶).
Zero examples of any peptides having non-standard peptide bonds were reduced to practice (see, e.g., Spec. filed 4/28/2023 at pages 21 at lines 8-17).
Zero examples of any peptides comprising non-standard amino acids were reduced to practice (see, e.g., Spec. filed 4/28/2023 at pages 20-21 at bridging ¶).
Zero examples of functional sequences lacking SEQ ID NO: 6 were reduced to practice (i.e., KTFK), and zero embodiments comprising motifs of XSXR, XSXK, or XTXR (i.e., other generic motifs within SEQ ID NO: 5) were reduced to practice or shown to be functional at all.
Accordingly, although the disclosure attempts to draw a fence around an infinitely large genus of diverse structures, including cyclic, branched, and linear peptides with an assortment of modifications, the record appears to show possession of a single, working peptide capable of satisfying the functional limitations set forth in the instant claims.
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 (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). 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 this case, the claims encompass an essentially infinite number of diverse peptides, but reduces to practice one example reading upon instant claim 1, and zero examples of any peptides comprising backbone modifications, cyclic features, D-amino acids, or non-natural amino acids substitutions.
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of two species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of 1, or zero species of the claimed invention does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Identifying characteristics of the genus
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, sufficient to show the applicant was in possession of the claimed genus.
As noted above, the description broadly generalizes about numerous structures (see, e.g., Spec. filed 4/28/2023 at page 19 at line 18 to page 24 at line 6), and vaguely identifies that the invention is intended to include “variants” of instant SEQ ID NOs: 1-7 (see, e.g., Spec. filed 4/28/2023 at page 16 at line 9 to page 17 at line 30), but such generic guidance fails to address or identify what compounds can actually achieve the functional outcomes recited at claims 1 and 6-10.
At best, the instant disclosure identifies that
In particular, disclosed is an isolated, synthetic peptide having about 4 to 30 amino acids, and which can bind to or be bound by to Protein Kinase C (PKC), either in vitro or in vivo. In some embodiments, the peptide minimally includes a Protein Kinase C consensus binding sequence, such as X-S/T-X-R/K (SEQ ID NO:5), wherein X is any amino acid.
However, this description identifies that SEQ ID NO: 5 (i.e., the tetramers of XSXR, XSXK, XTXR, or XTXK, wherein each X is independently any amino acid) is an example in “some” but not all embodiments. Notably, zero functional sequences lacking SEQ ID NO: 6 were reduced to practice (i.e., KTFK), and zero embodiments comprising motifs of XSXR, XSXK, or XTXR were reduced to practice or shown to be functional at all. This raises a significant issue since instant claim 5 currently recites any sequence having “at least 70% sequence identity to” instant SEQ ID NO: 1 or 4, because this limitation is presumed to satisfy 35 USC 112(d), which means that claim 1 and claim 5 encompass variants of SEQ ID NO: 1 lacking KTFK or any motif of SEQ ID NO: 5 (e.g., HRKKRRQRRITRKWWWWEVA shares 80% identity with instant SEQ ID NO: 1 and reads on instant claim 5 and presumably claim 1, but lacks the minimal motif corresponding to SEQ ID NO: 5). Accordingly, a basic threshold question is whether or not such a sequence is included or excluded by the instant claim scope. However, based on the disclosure, it is prima facie unclear if the structure does or does not read on the pending claims a priori and without making, testing, and infringing upon the pending claim scope.
Accordingly, although the functional limitations at claims 1 and 6-10 are presumably satisfied by all species within the scope of instant claim 5, it is unclear what other compounds are included or excluded from the pending claim scope.
The prior art provides no additional guidance on this issue, and therefore the instant description is insufficient to clearly inform artisans that Applicant had possession of the full scope of the pending claims.
Accordingly, the functional limitations of instant claims 1 and 6-10 appear to only be utilized as a vague attempt to capture unknown and undisclosed structures, sufficient to achieve some functional result that Applicant hopes and desires that the disclosed invention is able to achieve. However, the disclosure but does not meaningfully disclose an unambiguous structure/function relationship permitting an artisan to identify, a priori, which exact structures do or do not satisfy the functional limitations at issue.
Accordingly, basic identifying characteristics pertinent to the claimed genus are left unanswered, including “which compounds do or do not satisfy the limitations of instant claims 1-3 and 5-12?
Predictability in the Art
Although the level of skill in the art is high, the predictability in the art is low due to the complexity of biological systems, biochemistry, and lack of biophysical characterizations of peptide structures commensurate in scope with the instant functional limitations as claimed. Specifically, an artisan would not be able to predict or identify, a priori, and in the absence of any guidance or consensus structures exactly what compounds would be capable of satisfying the functional limitations of instant claims 1 and 6-10.
Accordingly, in the absence of sufficient structure/function teachings identifying particular compounds included or excluded by the functional limitations of the pending claims, as required to practice the full scope of the claims, an artisan would not reasonably conclude that Applicant possessed the full scope of the broad and highly varied claim scope.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). In addition, the Courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is pertinent because, in the instant case, Applicants have claimed a broad and highly varied genus comprising an unknown number of species defined by reference to one or more functional limitations; however, the originally filed disclosure has failed to identify any common structure/function relationship sufficient to permit an artisan to identify what structures are included or excluded by the claim scope. This also means that it is prima facie unclear what structures infringe or do not infringe upon the pending claim scope.
In conclusion, for the reasons discussed above, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Accordingly, claims 1-3 and 5-12 are rejected.
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)(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.
(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 1-3 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piazza et al.1.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above and in preceding rejections, and those interpretations are incorporated into the instant rejection. For purposes of the instant rejection, it is reasonably assumed that species satisfying the structural limitations of instant claim 5 necessarily satisfy the functional limitations and indefinite limitations of claims 1 and 6-10.
Regarding instant claims 1-3 and 5-10, Piazza teaches and discloses a 22-mer synthetic peptide consisting of TRKKTFKEVANAVKISASLMGT (see, e.g., Piazza at 1242 at col I at 2nd ¶). This structure comprises instant SEQ ID NOs: 5 and 6 (see underlined portion above), and shares 10/11 residues with instant SEQ ID NO: 4, which is 90.90% sequence identity. Accordingly, Piazza is understood to satisfy all structural requirements of instant claims 2-3 and 5. As noted above, the indefinite functional limitations of claims 1 and 6-10 are presumably satisfied by all structures satisfying the structural requirements of instant claim 5 for purposes of the instant rejection. Regarding instant claims 10-11, Piazza identifies that the sequence was synthesized and purchased, commercially (see, e.g., Piazza at 1242 at col I at 2nd ¶), and utilized in pharmaceutical assays with excipients (see, e.g., Piazza at 1242 at col I at 3rd ¶ and col II at 4th full ¶), wherein it is understood that a plurality of molecules of the peptide would be present. Accordingly, artisans would at once envisage the sequence purified and in a solvent suitable for use in the described assays.
Accordingly, claims 1-3 and 5-12 are anticipated by the prior art.
Allowable Subject Matter
The elected species, namely a peptide consisting of instant SEQ ID NO: 1, is free from the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 Piazza et al., Solution structure of calmodulin bound to the target peptide of endothelial nitric oxide synthase phosphorylated at Thr495. Biochemistry. 2014 Mar 4;53(8):1241-9. doi: 10.1021/bi401466s. Epub 2014 Feb 17. PMID: 24495081; hereafter “Piazza”.
Prosecution Insights