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 .
Status of the Claims
Claims 1-30 were originally filed April 13, 2022.
The preliminary amendment received April 13, 2022 amended claims 2, 6, 10-12, 16, 20, 25, and 29 and canceled claims 3, 7-9, 17, 21, 22, 26, and 30.
The amendment received March 10, 2025 amended claims 2, 4, and 5.
The amendment received August 20, 2025 amended claims 1, 2, 4-6, 10, and 11; canceled claims 12-16, 18-20, 23-25, and 27-29; and added new claims 31-35.
Claims 1, 2, 4-6, 10, 11, and 31-35 are currently pending.
Claims 1, 2, 5, 6, and 33 are currently under consideration.
Please note: claim 31 may contain a typographical error (i.e. peptide instead of peptide 2). Claim 31 also appears indefinite in nature. It is unclear what “opposite the linker” means and/or what the final structure required by the claim is.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1, 2, 4-6, and 10-12) in the reply filed on March 10, 2025.
Claims 13-16, 18-20, 23-25, and 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim.
Applicants elected, without traverse, SEQ ID NO: 5 (heparin binding domain of VEGF-a 125) for protein 1 (affinity for a growth factor or a growth factor receptor), two 6 amino-hexanoic acid spacers, SEQ ID NO: 25 (PDGF-BB) for protein 2 (affinity for an extracellular matrix protein). n = 2, binding the bipeptide to a polymer, and an amount sufficient to treat an injured tendon and/or ligament in the reply filed on March 10, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Please note: simply stating “with traverse” without a specific traversal is considered not distinctly and specifically pointing out any supposed errors.
Claims 4, 10, 11, 31, 32, 34, and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 10, 2025.
Please note: claims 31 is withdrawn because it appears the structure is not what was originally elected.
Please note: claim 32 is withdrawn because applicants did not elect concatamers.
Please note: claims 34 and 35 are withdrawn because the claims contain nonelected SEQ ID NOs: 1-4.
Please note: it appears that the elections for proteins 1 and 2 have been reversed since protein 1 should have “affinity” for a growth factor or a growth factor receptor and protein 2 should have “affinity” for an extracellular matrix protein. It is unclear why applicants picked species for peptides 1 and 2 from claim 5 which only refers to a Markush group for peptide 2. Although, from the specification and the prior art, it appears that SEQ ID NO: 25 has been mischaracterized as having affinity for an extracellular matrix (protein 2, claim 5). At paragraphs 48 and 49 of the present specification, it appears that SEQ ID NO: 25 actually has “affinity for PDGF-BB” (i.e. growth factor). In addition, applicants mischaracterized the function of SEQ ID NO: 5 as having “affinity” for heparin while the specification clearly teaches “affinity for collagen” (see page 8).
Please note: the claims do not require two 6 amino-hexanoic acid spacers, therefore, the rejections of record do not require two 6 amino-hexanoic acid spacers.
Please note: the election of an amount sufficient to treat an injured tendon and/or ligament is a vague subgenus and not a single, specific species. Therefore, the vague subgenus was searched.
Please note: see page 8 and paragraphs 48 and 49 regarding the present SEQ ID NOs:.
SEQ ID NO: 1 – “affinity” for TGF-b1 (peptide 1)
SEQ ID NO: 2 – “affinity” for VEGF (peptide 1)
SEQ ID NO: 3 – “affinity” for BMP-2 (peptide 1)
SEQ ID NO: 4 – “affinity” for FGF (peptide 1)
SEQ ID NO: 25 – “affinity” for PDGF-BB (peptide 1)
SEQ ID NO: 5 – “affinity” for collagen (peptide 2)
SEQ ID NO: 6 – “affinity” for fibronectin (peptide 2)
SEQ ID NO: 7 – “affinity” for hyaluronan (peptide 2)
SEQ ID NO: 8 – “affinity” for heparin (peptide 2)
SEQ ID NO: 9 – “affinity” for hydroxyapatite (peptide 2)
Potential Rejoinder
Applicants elect claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Priority
The present application is a 371 (National Stage) of PCT/US2020/057090 filed October 23, 2020 which claims the benefit of 62/926,180 filed October 25, 2019.
Withdrawn Objections
The objection to the abstract regarding “method using” should read “method of using” is withdrawn in view of the amendment received August 20, 2025.
The objection to claim 2 regarding “a collagen, fibronectin, hyaluronan, hydroxyapatite, or a heparin binding peptide” should read “a collagen binding peptide, a fibronectin binding peptide, a hyaluronan binding peptide, a hydroxyapatite binding peptide, and a heparin binding peptide” (i.e. insertion of articles and “binding peptide” for each and utilization of “and” with the closed Markush group) is withdrawn in view of the amendment received August 20, 2025.
The objection to claim 5 regarding the conjunction “and” should be utilized with the closed Markush group is withdrawn in view of the amendment received August 20, 2025.
The objection to claim 6 regarding “selected from” should read “selected from the group consisting of” is withdrawn in view of the amendment received August 20, 2025.
The objection to claim 6 regarding the conjunction “and” should be utilized with the closed Markush group (see second to last line) is withdrawn in view of the amendment received August 20, 2025.
Maintained Objections
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraph 6.
Arguments and Response
Applicants’ arguments directed to the objection to the specification due to an embedded hyperlink and/or other form of browser-executable code were considered but are not persuasive for the following reasons.
Applicants contend that the amendment received August 20, 2025 negates the objection.
Applicants’ arguments are not convincing since the amendment received August 20, 2025 simply altered one form of browser-executable code for another form of a browser-executable code.
Claim Objections
Claim 2 is objected to because of the following informalities: “a TGF-b1, VEGF, BMP-2, PDGF, or an FGF binding peptide” should read “a TGF-b1 binding peptide, a VEGF binding peptide, a BMP-2 binding peptide, a PDGF binding peptide, and an FGF binding peptide” (i.e. insertion of articles and “binding peptide” for each and utilization of “and” with the closed Markush group). Appropriate correction is required.
Arguments and Response
Applicants’ arguments directed to the objection to claim 2 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment received August 20, 2025 negates the objection.
Applicants’ arguments are not convincing since the amendment received August 20, 2025 did not make the suggested amendments.
Withdrawn Rejections
The rejection of claims 1, 5, 6, and 12 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 is withdrawn in view of the amendment received August 20, 2025.
The rejection of claims 1, 2, 5, 6, and 12 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 is withdrawn in view of the amendment received August 20, 2025.
The rejection of claim 5 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 is withdrawn in view of the amendment received August 20, 2025.
The rejection of claim 6 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 is withdrawn in view of the amendment received August 20, 2025.
The rejection of claim 12 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 is withdrawn in view of the amendment received August 20, 2025 wherein the claim was canceled.
The rejection of claim 5 on the basis that it contains an improper Markush grouping of alternatives is withdrawn in view of the amendment received August 20, 2025.
The rejection of claim 6 on the basis that it contains an improper Markush grouping of alternatives is withdrawn in view of the amendment received August 20, 2025.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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, 2, 5, 6, and 33 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if one of skill in the art would interpret the “chemical” linker of independent claim 1 as a peptide or a nucleic acid (i.e. presumably a polynucleotide and not a single nucleic acid).
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.
Claim 33 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 33 depends on independent claim 1. Independent claim 1 requires a chemical linker. Dependent claim 33 refers to chemical linkers of a small molecule, a carbohydrate, and a lipid. However, the claim also refers to a peptide and a nucleic acid (i.e. presumably a polynucleotide and not a single nucleic acid). One of skill in the art would not readily interpret a chemical linker as also including a peptide or a nucleic acid (i.e. presumably a polynucleotide and not a single nucleic acid). 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 33 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 33 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: small molecules, peptides, polynucleotides, carbohydrates, and lipids all have different structures/building blocks/etc.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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.
(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, 2, 6, and 33 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Hubbell et al. WO 2019/094938 published May 16, 2019 and/or U.S. Patent 11,732,029 (effective filing date of November 13, 2017).
For present claims 1, 2, 6, and 33, Hubbell teaches fusion polypeptides of a growth factor binding domain (SEQ ID NO: 1 which has 100% identity and the same length as present SEQ ID NO: 25) and a collagen binding peptide (i.e. ECM binding peptide) wherein linkers are present including peptide linkers and the fusion polypeptide may have more than two peptides and be attached to a polymer and molecules at various dosages (please refer to the entire specification particularly the abstract; paragraphs 3-5, 11-13, 17, 20-22, 39, 73-80, 84, 89-92, 94-96, 100, 101, 125-131, 133-137, 140-142, 145-148). Hubbell also teaches growth factor binding peptides to VEGF, VEGF-A, PDGF, PDGF-BB, PDGF-CC, BMP, BMP-2, FGF, and FGF-2 (please refer to the entire specification particularly paragraphs 5, 20, 21, 80).
Therefore, the presently claimed molecule is anticipated by Hubbell.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) and/or 102(a)(2) as being anticipated by Hubbell et al. for claims 1, 2, 6, and 33 were considered but are not persuasive for the following reasons.
Applicants contend that Hubbell et al. does not teach the presently claimed structure because Hubbell et al. teach a custom polypeptide with a growth factor binding domain and is attached to a transglutaminase reactive peptide to enhance growth mediated healing whereas the present molecules are designed to connect growth factors directly to tissue structures or cells as a bridge to increase healing efficacy.
Applicants’ arguments are not convincing since the teachings of Hubbell et al. anticipate the molecule of the instant claims. Hubbell et al. teach peptides comprising a growth factor binding domain, linkers, and a collagen binding peptide and/or an EMC-binding domain (please refer to the entire specification particularly the abstract; paragraphs 5, 11-13, 20, 21).
The attachment of a transglutaminase-reactive peptide is only for some embodiments (see paragraph 8).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989).
Claims 1, 2, 6, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanks et al. WO 2018/057522 published March 29, 2018.
For present claims 1, 2, 6, and 33, Shanks et al. teach PEGylated fusion polypeptides comprising a TGF-b1 antagonist, linkers including peptide linkers, and collagen or heparin anchor domains (i.e. collagen binding or heparin binding) at therapeutically effective amounts (please refer to the entire specification particularly the abstract; pages 1-4, 6, 7, 10, 12, 15, 17, 18, 23, 24, 28, 29, 31-34).
Therefore, the teachings of Shanks et al. anticipate the presently claimed molecule.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Shanks et al. for claims 1, 2, 6, and 33 were considered but are not persuasive for the following reasons.
Applicants contend that since Shanks et al. teaches an anchor domain for utilization in ocular surfaces that Shanks et al. cannot be utilized. Please note: applicants’ representative refers to both Hubbell et al. and Shanks et al. in the response received August 20, 2025 (see pages 10-11). Only the references to Shanks et al. are discussed since the present rejection of record only utilizes Shanks et al. as prior art.
Applicants’ arguments are not convincing since the teachings of Shanks et al. anticipate the molecule of the instant claims. Shanks et al. teach fusion proteins comprising a collagen-binding domain and/or a heparin-binding polypeptide, linkers, and TGFb antagonists (please refer to the entire specification particularly the abstract; pages 2-4, 6, 7, 29). Furthermore, the collagen-binding domain and heparin-binding polypeptide ARE the anchor domain (please refer to the entire specification particularly pages 6, 10).
In addition, the present molecule has open comprising language that allows for additional structure to be present.
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, 2, 5, 6, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Hubbell et al. WO 2019/094938 published May 16, 2019 and/or U.S. Patent 11,732,029 (effective filing date of November 13, 2017) and Chung et al. WO 2008/150119 published December 11, 2008.
For present claims 1, 2, 5, 6, and 33, Hubbell teaches fusion polypeptides of a growth factor binding domain (SEQ ID NO: 1 which has 100% identity and the same length as present SEQ ID NO: 25) and a collagen binding peptide (i.e. ECM binding peptide) wherein linkers are present and the fusion polypeptide may have more than two peptides and be attached to a polymer and bipeptides at various dosages (please refer to the entire specification particularly the abstract; paragraphs 3-5, 11-13, 17, 20-22, 39, 73-80, 84, 89-92, 94-96, 100, 101, 125-131, 133-137, 140-142, 145-148). Hubbell also teaches growth factor binding peptides to VEGF, VEGF-A, PDGF, PDGF-BB, PDGF-CC, BMP, BMP-2, FGF, and FGF-2 (please refer to the entire specification particularly paragraphs 5, 20, 21, 80).
For present claims 1, 2, 5, 6, and 33, Chung et al. teach SEQ ID NO: 28 (100% identity and the same length as present SEQ ID NO:5) in polymers (please refer to the entire specification particularly the abstract; pages 1, 2, 5-7).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (e.g. genus of collagen binding peptide) for another (i.e. species of SEQ ID NO: 28/SEQ ID NO: 5) would have yielded predictable results (i.e. binding to collagen) to one of ordinary skill in the art at the time of the invention. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Hubbell et al. and Chung et al. for claims 1, 2, 5, 6, and 33 were considered but are not persuasive for the following reasons.
Applicants contend that Hubbell et al. does not teach the presently claimed structure because Hubbell et al. teach a custom polypeptide with a growth factor binding domain and is attached to a transglutaminase reactive peptide to enhance growth mediated healing whereas the present molecules are designed to connect growth factors directly to tissue structures or cells as a bridge to increase healing efficacy. Applicants contend that Chung et al. only teaches a peptide in a gel forming material.
Applicants’ arguments are not convincing since the teachings of Hubbell et al. and Chung et al. render the molecule of the instant claims prima facie obvious.
Hubbell et al. teach peptides comprising a growth factor binding domain, linkers, and a collagen binding peptide and/or an EMC-binding domain (please refer to the entire specification particularly the abstract; paragraphs 5, 11-13, 20, 21).
The attachment of a transglutaminase-reactive peptide is only for some embodiments (see paragraph 8).
Chung et al. teach SEQ ID NO: 28 (100% identity and the same length as present SEQ ID NO:5) in polymers (please refer to the entire specification particularly the abstract; pages 1, 2, 5-7).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See WO 2018/101826 regarding the sequences in present claim 4.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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