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 Application
The claims of 30 May 2023 are entered.
Claims 1-15 are pending and are being examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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.
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 6 and 7 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.
Claim 6 recites the limitation "the carbon terminal, the amine terminal" in line 5. There is insufficient antecedent basis for this limitation in the claim.
In claim 7, the claim recites “FP-353 (SEQ ID NO: 17 to SEQ ID NO: 24) in which FP-3 is fused to both terminals of FP-5”. However, in SEQ ID NOs: 17-23 there is no evidence that FP-3 is fused to the N- and C-termini of FP-5. Rather SEQ ID NOs: 17-21 are a fusion of FP-1 to FP-5, SEQ ID NO: 22 is a fusion of FP-1 to FP-3, and SEQ ID NO:23 is a fusion of FP-2 to FP-5 and FP-1. The claim language is inconsistent with the disclosed sequences, leading one of ordinary skill in the art to not have a clear understanding of the metes and bounds of the claim.
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.
1. Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR20160144073A (published 16 December 2016,as cited on IDS of 30 May 2023, hereafter referred to as ‘073).
The Examiner notes that claim 1 contains the language “for preventing or treating inflammatory diseases” in the preamble. Per MPEP 2111.02,
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase "treating a cancer" "’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells."); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase "rich in glucosinolates" helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently "rich in glucosinolates")).
In this case, the preamble merely states the purpose or intended use of the claimed composition with the body of the claim fully and intrinsically sets forth all limitations. Therefore, the intended use is of no significance to claim construction. Claims 2 and 3 further restrict the inflammatory disease, but again the prevention or treatment is not of significance to claim construction and as such the further species of of claims 2 and 3 are similarly not viewed as limitations.
Similarly, the language “for ameliorating inflammatory diseases” in claim 12 is given no patentable weight, as it merely expresses an intended use of the composition. Claim 15 further limits the inflammatory disease, but the base amelioration of inflammatory disease is not given patentable weight and as such the further limitation of the inflammatory disease is also given no patentable weight.
As to the preamble language of “pharmaceutical composition” or “cosmetic composition”, again these are merely expressing intended uses of the claimed composition, as the body sets forth that the only structural requirement is a recombinant polypeptide where a functional peptide is conjugated at a biocompatible polypeptide. In this case, the body of the claim fully and intrinsically sets forth all claim limitations.
The ’073 application discloses a recombinant polypeptide having a functional peptide bound to an adhesive protein (see e.g. claim 1). Furthermore, the adhesive protein is claimed as a mussel adhesive protein (see e.g. claim 3). This anticipates claims 1 and 12.
With respect to claims 2 and 3, as set forth above the further restrictions on the inflammatory diseases are not considered to be of significance to claim construction since the inflammatory disease is part of an intended use.
With respect to claims 4, 5, and 13, the polypeptide of ‘073 is a mussel adhesive protein selected from Mytilus edulis, Mytilus galloprvincialis, and Mytilus coruscus.
With respect to claims 6 and 7, ‘073 discloses a fusion FP-151 where FP-1 of SEQ ID NO: 1-3 is fused at the N- and C-terminus of FP-5 of SEQ ID NO: 10-13, leading to SEQ ID NOs: 15-17 (see e.g. claim 3). ‘073 also discloses FP-131 of SEQ ID NO:18 and FP-251 of SEQ ID NO: 19 (see e.g. claim 3).
With respect to claims 8, 9, and 14, ‘073 discloses an antibacterial peptide fusion (see e.g. claims 4-7).
With respect to claim 10, the conjugates of ‘073 are directly linked as in FP-151, FP-131, and FP-251.
With respect to claim 11, ‘073 discloses SEQ ID NOs: 20-31, overlapping with SEQ ID NOs: 29-34 and 36-40 (see e.g. claim 7).
2. Claims 1-5, 8, 10, 12, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahn et al. (Immunological Investigations 48:242-254, published 6 September 2018, as cited on IDS of 30 May 2023, hereafter referred to as Ahn).
The Ahn art discloses a fusion of human vitronectin with a mussel adhesive protein polypeptide (see e.g. Figure 1B) In particular a construct is prepared having the structure (FP-1)-(FP-5)-(FP-1)-(vitronectin). FP-1 in Ahn matches SEQ ID NO: 5, i.e. a repeat of six sequences. This is linked to FP-5 via a GC linker at the N-terminus and a EFEF linker at the C-terminus. Finally the vitronectin is attached to the C-terminus of FP-1 via a KL linker. As noted above the intended use is not considered a claim limitation. Even disregarding this, Ahn discloses that the compound is anti-inflammatory (see e.g. Result). This anticipates claims 1 and 12.
With respect to claims 2 and 3, as set forth above these species are not considered a limitation as they reflect the intended use. Disregarding this, at least claim 2 is anticipated by Ahn as it suggests utilization in skin inflammation (see e.g. p.252).
With respect to claims 4, 5, and 13 the Ahn art discloses mussel adhesive proteins.
With respect to claim 8, vitronectin is an extracellular matrix protein.
With respect to claim 10, as set forth above short peptide linkers join the FP-151 to the vitronectin.
With respect to claim 15, as set forth above the further restrictions of inflammatory disease are not considered to be claim limitations since they reflect the intended use of the composition.
3. Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee S and Hong B (US20180327643 A1, published 15 November 2018, hereafter referred to as ‘643).
The ‘643 application claims a fusion comprising an amphiphilic peptide comprising SEQ ID NO:31 and an adhesive protein derived from mussel adhesive protein comprising FP-151, FP-131, and FP-251 (see e.g. claims 1-6). SEQ ID NO: 31 is identical to SEQ ID NO: 29 as instantly claimed. SEQ ID NO: 15 of ‘643 is identical to SEQ ID NO: 19 as instantly claimed. As noted above, both claims 1 and 12 are interpreted as expressing intended uses. However, ‘643 does suggest cosmetic usage (see e.g. Abstract). The ‘643 application therefore anticipates claims 1 and 12.
With respect to claims 2, 3, and 15, as set forth above these species are viewed as limitations to the intended use and are not considered to be of significance to claim construction.
With respect to claims 4-7 and 13, as discussed above the ‘643 construct reads upon each claim as it overlaps with SEQ ID NO: 19 comprising FP-1 fused to both termini of FP-5.
With respect to claims 8-11 and 14, SEQ ID NO: 31 of ‘643 reads upon an antimicrobial peptide.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
US 2021/0070816 A1, published 11 March 2021, priority to 7 August 2015: discloses the same features as in US20180327643 A1.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658