Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AlA” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Reissue: Final Office Action
Status of the Claims
The amendments and arguments filed Aug. 7, 2025 are acknowledged and have been fully considered. Claims 1-8, 42-49, 115, 116, and 119-124 are now pending and are now under consideration. Claims 9-41, 50-114, 117, 118, and 125-128 are cancelled; claim 116 has been amended since the last Office action.
OBJECTIONS/REJECTIONS WITHDRAWN
The objection to the specification is withdrawn in light of the certificate of correction filed 8/7/2025.
The objection to claims 42-49, 115, 116, and 119-124 is withdrawn in light of the amendments in instant claim set, which show the proper markings.
The rejection of claim 116 under 35 U.S.C. 112, 2nd paragraph/(b) is withdrawn in light of the claim amendments.
The rejection of claims 115-116 and 120-124 under 35 U.S.C. 103(a) over WOZNEY, POHL, and BOTCHKAREV is withdrawn in favor of the new rejection presented herein.
The rejection of claims 125-128 under 35 U.S.C. 103(a) over RUEGER and LEE is moot in light of the claim cancellations.
Claim Rejections - 35 USC § 112 (2nd Paragraph)
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.
Claims 120-124 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 pre-AIA the applicant regards as the invention.
Claims 120-124 are indefinite in the recitation "an aesthetically undesirable condition of the skin" in claim 120. The term/phrase "aesthetically undesirable condition" is subjective and is not defined in a limiting way in the specification. Reasonable persons can disagree about what constitutes "an aesthetically undesirable condition", and what is "aesthetically undesirable" to one person may be "aesthetically desirable" to another. See MPEP § 2173.05(b)(IV) regarding subjective terms. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103 (New)
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 115-116 and 120-124 are rejected under 35 U.S.C. 103(a) as being unpatentable over WOZNEY (US 5,700,911) in view of FORE (Fore, J. A., Wound Management and Prevention (2006), 1-12; accessed online 9/30/25 at https://www.hmpgloballearningnetwork.com/site/wmp/content/a-review-skin-and-effects-aging-skin-structure-and-function).
Regarding claim 115, A method of treating an age-related condition of the skin, the method comprising administering to a mammalian subject a pharmaceutical composition comprising a mammalian GDF 11 polypeptide, whereby the pharmaceutical composition increases the level of Growth Differentiation Factor 11 (GDF 11) polypeptide in the subject:
Wozney teaches pharmaceutical compositions comprising an isolated BMP-11 (a.k.a. GDF 11) polypeptide, which may be recombinant (col. 16 line 44; claims 2 and 7-12). The compositions comprise a pharmaceutically acceptable carrier: “pharmaceutical compositions containing a therapeutically effective amount of a BMP-11 protein in a pharmaceutically acceptable vehicle or carrier”; (col. 4, lines 22-25; claims 8-12). Note that the BMP-11 of Wozney is identical to the GDF-11 instantly claimed. For example, Wozney's claim 2 is directed to “the polypeptide consisting of” the C-terminal 109 residues SEQ ID No. 11, and Wozney teaches the GDF11 polypeptide is a homodimer (col. 1, lines 38-41; col. 13, lines 4-29). See the sequence alignment below, which compares the C-terminal 109 residues of Wozney's SEQ ID No. 11 with instant SEQ ID NO: 14:
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379
739
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showing the C-terminal 109 residues are identical to instant SEQ ID NO: 14.
Wozney teaches topical administration of the pharmaceutical compositions for wound healing and tissue repair (col. 1, lines 14-19; col. 4 lines 50-56; col. 9, lines 44-58; col. 10, line 62 to col. 11, line 7). It is noted that applicants define age-related condition of the skin (claim 115) and an aesthetically undesirable condition of the skin (claim 120) expansively to include "reduced regenerative capacity" (see col. 9, lines 16-39 of the '779 Patent).
The instant application defines "age-related condition" as any disease, disorder, or undesirable state whose incidence in a population or severity in an individual correlates with the progression of age to include reduced regenerative capacity (e.g., see col. 9, lines 16-30 of the ‘799 patent).
As known in the art wound healing is a skin condition whose efficiency is negatively correlated with the aging. For example, Fore reviews the effects of aging on skin structure and function (title; abstract). Fore teaches that wound healing slows with aging (p. 1, 2nd to last par.; p. 5, last par.; p. 6, 2nd-4th pars., section entitled "Anatomic and Developmental Changes Associated With Aging"). Skin wounds are thus "age-related conditions of the skin" within the meaning of the instant claims, because aging skin (and wounded skin) is characterized by "reduced regenerative capacity" (per Fore). It is obvious to use a compound known to have wound healing and tissue repair activities in the treatment of skin wounds. The selection of a known material based on its suitability for its recognized intended use is prima facie obvious. See MPEP § 2144.07. Thus, the treatment of topical wounds as suggested by Wozney reads on treating an age-related condition of the skin as well as improving an aesthetically undesirable condition of the skin.
Regarding claim 116: wherein the age-related condition of the skin is skin atrophy: Fore teaches, "The general anatomical changes of the skin associated with aging result in atrophy, laxity, wrinkling, sagging, dryness, pigment and blemish development, neoplasms, and nail and hair changes." (p. 6, under "Clinical Skin Changes Associated With Aging"). Since aged skin is generally characterized by skin atrophy, the use of BMP-11 on aged, wounded skin would also necessarily treat skin atrophy due to aging.
Regarding claim 120, skin wounds are also considered "an aesthetically undesirable condition of the skin" as broken (i.e., wounded) skin is reasonably aesthetically undesirable to many persons. See the indefiniteness rejection regarding the phrase "an aesthetically undesirable condition of the skin" above.
Regarding claim 121: wherein the undesirable condition is wrinkles: Fore teaches, "The general anatomical changes of the skin associated with aging result in atrophy, laxity, wrinkling, sagging, dryness, pigment and blemish development, neoplasms, and nail and hair changes." (p. 6, under "Clinical Skin Changes Associated With Aging") Since aged skin is generally characterized by wrinkles, the use of BMP-11 on aged, wounded skin would also necessarily treat wrinkles.
It is further noted that none of the claims require administration to a subject "in need thereof", or administration to a specific mammalian population. All that is required is administration to some mammalian subject. Further, the claims do not require a "therapeutically effective amount" of GDF11. Nor do the claims require administration by any particular route (e.g., oral, topical, parenteral, etc.). Thus, as the claims are currently drafted, administration of GDF11 to any aged (construed as "adult") mammalian subject by any route meets the claim. In other words, a subject need not actually have skin atrophy or wrinkles in order to meet claims 116 or 121, respectively, although Fore teaches these conditions. The recitations of treating skin atrophy (claim 116) and improving wrinkles (claim 121) are intended outcomes of the positive active steps recited in the claims, as currently drafted. MPEP § 2111.04, states that language that suggests or makes optional but does not require steps to be performed does not limit the claim scope. Additionally, a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Note that "whereby" and "wherein" are construed to have the same meaning. Since no additional steps are recited in order to treat skin atrophy or improve wrinkles as instantly claimed, these intended outcomes must flow from the recited step of administration of GDF11, and this language does not limit the claim scope and does not add patentable weight to the claim.
Regarding claim 123: The method of claim 120, wherein the pharmaceutical composition comprises a homodimer of a GDF 11 polypeptide selected from SEQ ID NO: 1, SEQ ID NO:2, and SEQ ID NO: 14, Wozney teaches the same sequence of SEQ ID NO: 14 (claim 2: “BMP-11 … polypeptide consisting of the amino acid sequence from amino acid #1 to #109 as set forth in SEQ ID NO:11”; aka GDF-11, as described in the sequence alignment discussed above) as well as the homodimer (col. 1, lines 38-41; col. 13, lines 4-29: “It is contemplated therefore that the mature active species of BMP-11 comprises a homodimer of two polypeptide subunits, each subunit comprising amino acids #1 to #109 with a predicted molecular weight of approximately 12,000 daltons.”).
Regarding claim 124: The method of claim 120, wherein the pharmaceutical composition comprises an isolated and recombinant GDF 11 polypeptide and a pharmaceutically acceptable carrier, the GDF 11 polypeptide consisting of a disulfide linked homodimer of the peptide consisting of the amino acid sequence of SEQ ID NO: 14, as with claim 123 Wozney teaches the GDF-11 polypeptide may be recombinant (col. 16 line 44; claims 2 and 7-12), and teaches the GDF-11 proteins in a pharmaceutically acceptable vehicle or carrier (col. 4, lines 23-25; claims 8-12). Wozney teaches the GDF-11 protein is a homodimer (col. 1, lines 38-41; col. 13, lines 4-29), and teaches that such dimers are disulfide linked (col. 10, lines 6-7: “composition of the invention may comprise a disulfide linked dimer comprising a BMP-11 protein”). Wozney teaches the same sequence of SEQ ID NO: 14 (claim 2: “BMP-11 … polypeptide consisting of the amino acid sequence from amino acid #1 to #109 as set forth in SEQ ID NO:11”; aka GDF-11, as described in the sequence alignment discussed above).
Summary/Conclusion
Claim 115, 116, and 120-124 are rejected; claims 9-41, 50-114, 117, 118, and 125-128 are cancelled; claims 1-8, 42-49, and 119 are allowable.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Speer can be reached at (313) 446-4825. The fax phone number for the organization where this application or proceeding is assigned is 571-273-9900.
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/Kevin S Orwig/ Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991