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 Application, Amendments and/or Claims
The amendment, filed 14 April 2023, has been entered in full. The amendment, filed 31 October 23, has been entered in full. Claims 5, 6, 8 and 16 are amended. Claims 19-27 are canceled. The amendment, filed 16 December 2025, has been entered in full. Claims 1-18 are under examination.
Information Disclosure Statement
The information disclosure statement(s)(IDS) (filed 4/14/2023 and 1/7/2026) were received. They have been placed in the application file and the information referred to therein has been considered as to the merits.
It is noted that some of the references fail to comply with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. MPEP 609.05 [R-3] states that information disclosure statements will be reviewed for compliance with the requirements of 37 CFR 1.97 and 37 CFR 1.98 as discussed in MPEP 609.04(a) and MPEP 609.04(b). The references will be lined through and not considered by the Examiner.
References: The references should include the name of the author, title of the article, name of the item (i.e. book, magazine, Journal, symposium, catalog, etc.), the volume-issue number, the pages, and date.
The following references not considered by the Examiner for the following reasons:
1. The journal reference not considered by the Examiner are missing page numbers.
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).
DUPLICATE CLAIM WARNING
1. Applicant is advised that should claims 5 and 6 be found allowable, claim 8 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:
Claim 5 is drawn to the topical formulation of claim 1, wherein the M-T7 polypeptide has an amino acid sequence at least 80% identical to the amino acid sequence of SEQ ID NO:1.
Claim 6 is drawn to the topical formulation of claim 1, wherein the M-T7 polypeptide has an amino acid sequence at least 80% identical to the amino acid sequence of SEQ ID NO:2.
However, claim 8 is drawn to the topical formulation of claim 1, wherein the M-T7 polypeptide has a minimal amino acid sequence at least 80% identical to a polypeptide fragment within SEQ ID NO:1 or SEQ ID NO:2.
If claim 8 is not of similar scope to claims 5 and 6, Applicant is asked to specifically point in the specification and explain the patentable distinction between the claims.
2. Applicant is advised that should claim 14 be found allowable, claim 15 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:
Claim 14 is drawn to the topical formulation of claim 1, wherein the M-T7 polypeptide comprises one or more post-translation modifications.
However, claim 15 is drawn to the topical formulation of claim 1, wherein the M-T7 polypeptide comprises one or more modifications to a post-translational modification.
If the claims 14 and 15 are not of similar scope, Applicant is asked to specifically point in the specification and explain the patentable distinction between the claims.
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 1-10, 14-18 are rejected under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a1) as being anticipated by Lucas et al. (Reference submitted by Applicant; US 2018/093437; published July 12, 2018).
Lucas et al. teach polypeptides derived from the Myxoma virus-derived secreted glycoprotein, M-T7, comprising point mutations (abstract)(applies to claim 3). Lucas et al. teach that useful polypeptides can be produced by any methods known in the art, including by recombinant techniques (para 0072)(applies to claim 4).
Lucas et al. teach a polypeptide sequence that is 99% identical to instant SEQ ID NO:1 and a polypeptide sequence that is 98.5% identical to instant SEQ ID NO:2 (paras 0068-0070. See below, Sequence Result A and Sequence Search Result B, respectively)(applies to claims 3-6, 8 and 17).
It is noted that the intend use of the topical formulation is for promoting wound healing. Lucas et al. teach that compositions comprising the M-T7 derived polypeptides are useful in preventing, blocking and/or reducing rejection of a transplant and treating transplant vasculopathy (i.e. disease, damage, or dysfunction of blood vessels)(abstract and paras 0005 and 0043). Lucas et al. teach that the pharmaceutical compositions described herein can be delivered to the skin or to the external surfaces of organs (paras 0081 and 0109)(applies to claim 1). Lucas et al. teach that the pharmaceutical composition can be formulated for administration by any route of administration, including topical (para 0090)(applies to claim 1).
MPEP 2112.01 states: products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In the instant case, the recited purpose/intended use does not result in a structural difference between the claimed invention and the chemical composition from the prior art. A topical formulation comprising the chemical structures from the prior art (i.e. the polypeptide sequences taught by Lucas) would have the biological function of promoting wound healing (applies to claim 1).
Lucas et al. teach that the polypeptides can have (consist of) or include (comprise) a sequence as specifically set out herein or they can be biologically active fragments or analogs of any of these reference sequences. A fragment is different from a reference sequence by containing fewer contiguous amino acid residues (one or more amino acids from the N- or C-terminal are deleted)(para 0071)(applies to claim 7).
Lucas et al. teach that pharmaceutical compositions as described herein can comprise pharmaceutically acceptable carriers (paras 0076, 0078)(applies to claim 2). Lucas et al. teach that pharmaceutical composition can be formulated as a gel, paste, ointment, cream, lotion or spray (para 0087)(applies to claim 18). Lucas et al. teach that the pharmaceutical composition can include one or more additional therapeutic agents such as aspirin (paras 0110 and 0113)(i.e. pain reliever or an anti-inflammatory, applies to claims 9 and 10).
Lucas et al. teach that MT-7 polypeptide comprises several putative glycosylation sites and that expression in cells can permit core glycosylation thereby increasing the likelihood that bioactive M-T7 will be expressed (paras 0068 and 0070). In addition, Lucas et al. teach that that MT-7 polypeptide can be recombinantly produced. Lucas et al. teach expression from vector constructs in eukaryotic cells, which would allow post-translation modifications (para 0072)(applies to claims 14-16).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lucas et al. (Reference submitted by Applicant; US 2018/093437; published July 12, 2018) in view of Mousa et al. (US 2016/0206773; published July 21, 2016).
Lucas et al. teach polypeptides, derived from the Myxoma virus-derived secreted glycoprotein, M-T7, comprising point mutations (abstract)(applies to claim 3). Lucas et al. teach that compositions comprising the M-T7 derived polypeptides with point mutations are useful in preventing, blocking and/or reducing rejection of a transplant (abstract and para 0043). Lucas et al. teach that useful polypeptides can be produced by any methods known in the art, including by recombinant techniques (para 0072)(applies to claim 4). Lucas et al. teach a polypeptide sequence that is 99 % identical to instant SEQ ID NO:1 and a polypeptide sequence that is 98.5% identical to instant SEQ ID NO:2 (paras 0068-0070. See below, Sequence Result A and Sequence Search Result B, respectively)(applies to claims 3-6, 8 and 17). Lucas et al. teach that the polypeptides can have (consist of) or include (comprise) a sequence as specifically set out herein or they can be biologically active fragments or analogs of any of these reference sequences. A fragment is different from a reference sequence by containing fewer contiguous amino acid residues (one or more amino acids from the N- or C-terminal are deleted)(para 0071)(applies to claim 7).Lucas et al. teach that the polypeptides, compositions and/or pharmaceutical compositions described herein can be administered to any part of the donor's body and/or put in contact with any part of the transplant organ or tissue for subsequent delivery to a recipient. For example, a composition can be delivered to the skin or the external surfaces of organs (paras 0081 and 0109)(applies to claim 1). Lucas et al. teach that the pharmaceutical composition can be formulated for administration by any route of administration, including topical (para 0090)(applies to claim 1). Lucas et al. teach that pharmaceutical compositions as described herein can comprise pharmaceutically acceptable carriers (paras 0076, 0078)(applies to claim 2). Lucas et al. teach that pharmaceutical composition can be formulated as a gel, paste, ointment, cream, lotion or spray (para 0087)(applies to claim 18). Lucas et al. teach that the pharmaceutical composition can include one or more additional therapeutic agents such as aspirin (paras 0110 and 0113)(i.e. pain reliever or an anti-inflammatory, applies to claims 9 and 10). Lucas et al. teach that MT-7 polypeptide comprises several putative glycosylation sites and expression in cells can permit core glycosylation thereby increasing the likelihood that bioactive M-T7 will be expressed (paras 0068 and 0070). In addition, Lucas et al. teach that that MT-7 polypeptide can be recombinantly produced. Lucas et al. teach expression from vector constructs in eukaryotic cells, which would allow post-translation modifications (para 0072)(applies to claims 14-16).
Lucas et al. do not explicitly teach wherein the topical formulation is contained in a hydrophilic polymer.
Mousa et al. teach a composition and a method of applying a composition to a site on the body. Mousa et al. teach the composition includes a hydrogel matrix that includes at least one polymer cross-linked, via ionic or covalent bonding, with both hyaluronic acid and alginic acid. Mousa et al. teach that the at least one polymer is chitosan, poly L-Lysine, or a combination thereof. Mousa et al. teach that chitosan and poly L-Lysine are hydrophilic polymers (abstract and paras 0033 and 0079)(applies to claims 11-13). Mousa et al. teach using the composition for the treatment of wounds (paras 0002 and 0050). Mousa et al. teach the composition can be used as a drug delivery vehicle for growth factors and other biologically active agents (paras 0050 and 0064).
It would have been obvious for one of ordinary skill in the art before the effective filling date to modify a topical formulation for promoting wound healing comprising a therapeutically effective amount of an M-T7 polypeptide, as taught by Lucas et al, by adding the topical formulation to a hydrophilic polymer comprising a hydrogel, as taught by Mousa et al. One of ordinary skill in the art before the effective filing date, would have been motivated to make such modifications and expect success for the following reasons. Mousa et al. teach applying a composition comprising a hydrogel matrix that includes at least one hydrophilic polymer such as chitosan or poly L-Lysine crosslinked, via ionic or covalent bonding, with both hyaluronic acid and alginic acid on the body of a mammal. Mousa et al. teach that the composition comprising the hydrogel matrix can be employed for the treatment of wounds. Mousa et al. teach said composition can be used as a drug delivery vehicle for biologically active agents. Based on the teachings, it would be obvious to add a topical formulation comprising M-T7 to a composition comprising a hydrogel matrix, wherein the hydrogel matrix is taught to be applied topically to a wound.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.D/Examiner, Art Unit 1647 3/16/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
SEQUENCE SEARCH RESULT A
This page gives you Search Results detail for the Application 18032080 and Search Result 20260227_153026_us-18-032-080-1.minpct75.rapbm
Title: US-18-032-080-1
Perfect score: 1371
Sequence: 1 MDGRLVFLLASLAIVSDAVR..........EELYLTVASMFERLVEDVFE 263
SUMMARIES
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-----------------------------------------------------------------------------
1 1357 99.0 263 US-15-742-092-1 2018-01-05 0 COMPOSITIONS AND METHODS FOR REDUCING ORGAN REJECTION BY REDUCING HEPARAN SULFAT
ALIGNMENTS
RESULT 1
US-15-742-092-1
Sequence 1, US/15742092
Publication No. US20180193437A1
GENERAL INFORMATION
APPLICANT: University of Florida Research Foundation, Incorporated
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR REDUCING ORGAN REJECTION BY
TITLE OF INVENTION: REDUCING HEPARAN SULFATE IN DONOR TRANSPLANTS
FILE REFERENCE: U1197.70120US01
CURRENT APPLICATION NUMBER: US/15/742,092
CURRENT FILING DATE: 2018-01-05
PRIOR APPLICATION NUMBER: PCT/US2016/041372
PRIOR FILING DATE: 2016-07-07
PRIOR APPLICATION NUMBER: US 62/189,548
PRIOR FILING DATE: 2015-07-07
NUMBER OF SEQ ID NOS: 4
SEQ ID NO 1
LENGTH: 263
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
Query Match 99.0%; Score 1357; Length 263;
Best Local Similarity 99.2%;
Matches 261; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MDGRLVFLLASLAIVSDAVRLTSYDLNTFVTWQDDGYTYNVSIKPYTTATWINVCEWASS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MDGRLVFLLASLAIVSDAVRLTSYDLNTFVTWQDDGYTYNVSIKPYTTATWINVCEWASS 60
Qy 61 SCNVSLALQYDLDVVSWARLTRVGKYTEYSLEPTCAVARFSPPEVQLVRTGTSVEVLVRH 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 SCNVSLALQYDLDVVSWARLTRVGKYTEYSLEPTCAVARFSPPEVQLVRTGTSVEVLVRH 120
Qy 121 PVVYLRGQEVSVYGHSFCDYDFGYKTIFLFSKNKRAEYVVPGRYCDNVECRFSIDSQESV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PVVYLRGQEVSVYGHSFCDYDFGYKTIFLFSKNKRAEYVVPGRYCDNVECRFSIDSQESV 180
Qy 181 CATAVLTYGDSYRSEAGVEVCVPELAKREVSPYIVKKSSDLEYVKRAIHNEYRLDTSSEG 240
|||||||| ||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CATAVLTYDGSYRSEAGVEVCVPELAKREVSPYIVKKSSDLEYVKRAIHNEYRLDTSSEG 240
Qy 241 RRLEELYLTVASMFERLVEDVFE 263
|||||||||||||||||||||||
Db 241 RRLEELYLTVASMFERLVEDVFE 263
SEQUENCE SEARCH RESULT B
This page gives you Search Results detail for the Application 18032080 and Search Result 20260227_153026_us-18-032-080-2.minpct75.rapbm
Title: US-18-032-080-2
Perfect score: 1289
Sequence: 1 VRLTSYDLNTFVTWQDDGYT..........EELYLTVASMFERLVEDVFE 245
SUMMARIES
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-----------------------------------------------------------------------------
2 1270 98.5 263 US-15-742-092-2 2018-01-05 0 COMPOSITIONS AND METHODS FOR REDUCING ORGAN REJECTION BY REDUCING HEPARAN SULFAT
ALIGNMENTS
RESULT 2
US-15-742-092-2
Sequence 2, US/15742092
Publication No. US20180193437A1
GENERAL INFORMATION
APPLICANT: University of Florida Research Foundation, Incorporated
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR REDUCING ORGAN REJECTION BY
TITLE OF INVENTION: REDUCING HEPARAN SULFATE IN DONOR TRANSPLANTS
FILE REFERENCE: U1197.70120US01
CURRENT APPLICATION NUMBER: US/15/742,092
CURRENT FILING DATE: 2018-01-05
PRIOR APPLICATION NUMBER: PCT/US2016/041372
PRIOR FILING DATE: 2016-07-07
PRIOR APPLICATION NUMBER: US 62/189,548
PRIOR FILING DATE: 2015-07-07
NUMBER OF SEQ ID NOS: 4
SEQ ID NO 2
LENGTH: 263
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
Query Match 98.5%; Score 1270; Length 263;
Best Local Similarity 98.8%;
Matches 242; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 VRLTSYDLNTFVTWQDDGYTYNVSIKPYTTATWINVCEWASSSCNVSLALQYDLDVVSWA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 19 VRLTSYDLNTFVTWQDDGYTYNVSIKPYTTATWINVCEWASSSCNVSLALQYDLDVVSWA 78
Qy 61 RLTRVGKYTEYSLEPTCAVARFSPPEVQLVRTGTSVEVLVRHPVVYLRGQEVSVYGHSFC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 RLTRVGKYTEYSLEPTCAVARFSPPEVQLVRTGTSVEVLVRHPVVYLRGQEVSVYGHSFC 138
Qy 121 DYDFGYKTIFLFSKNKRAEYVVPGRYCDNVECRFSIDSQESVCATAVLTYGDSYRSEAGV 180
|||||||||||||||||||||||||||||||| ||||||||||||||||| ||||||||
Db 139 DYDFGYKTIFLFSKNKRAEYVVPGRYCDNVECEFSIDSQESVCATAVLTYDGSYRSEAGV 198
Qy 181 EVCVPELAKREVSPYIVKKSSDLEYVKRAIHNEYRLDTSSEGRRLEELYLTVASMFERLV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 199 EVCVPELAKREVSPYIVKKSSDLEYVKRAIHNEYRLDTSSEGRRLEELYLTVASMFERLV 258
Qy 241 EDVFE 245
|||||
Db 259 EDVFE 263