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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-16 and the species which reads on claims 1-13, 15, 16 in the reply filed on 3/12/2026 is acknowledged.
Therefore, claims 14, 17-20 are withdrawn from further consideration as being drawn to non-elected inventions.
Claim Rejections - 35 USC § 112
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, 3-13, 15, 16 are rejected under 35 U.S.C. 112, 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 reasonable convey to one skilled in the relevant art that the inventor (s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a composition for hydrogel comprising a phenol derivative modified, tissue derived extracellular matrix wherein the composition comprises a structure represented by Chemical formula I. Thus, the claims are drawn to a genus of compounds (and a genus of their use) that is defined only by their function. It is not clear what the “phenol derivative modified” actually is or what the “tissue derived extracellular matrix” actually is.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factor present in the claims is drawn to a hydrogel comprising a phenol derivative modified, tissue derived extracellular matrix wherein the composition comprises a structure represented by Chemical formula I. Thus, the claims are drawn to a genus of compounds (and a genus of their use) that is defined only by their function. It is not clear what the “phenol derivative modified” actually is or what the “tissue derived extracellular matrix” actually is.
The specification only teaches that the “phenol derivative” is derived from at least one of a catechol group as claimed in claim 2 and that the “tissue derived extracellular matrix” is derived from the sources in claim 3.
Accordingly, in the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus which encompassed the “phenol derived modified” or the “tissue derived extracellular matrix”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is now is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of inhibitors, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation or identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
The full breadth of the claims DO NOT meet the written description provision of 35 U.S.C. 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Applicant argues that the claims now recite that the composition comprises a structure represented by chemical formula I, but there still is no written description for “phenol derived modified” or tissue derived extracellular matrix”. The chemical structure I may be part of the composition for hydrogel, but it still lacks written description especially for “phenol derived modified” or tissue derived extracellular matrix”. The composition for hydrogel may include the structure of Chemical formula I but it is also clearly claimed that there can be more than just Chemical formula I in the “composition for hydrogel”. The claims encompass anything in addition to the Chemical Formula I. Without knowing what “phenol derived modified” or tissue derived extracellular matrix” actually represents the claims lack written description.
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, 3-13, 15, 16 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.
It is still not clear what a composition for hydrogel comprising a phenol derivative modified, tissue derived extracellular matrix wherein the composition comprises a structure represented by Chemical formula I is.
Applicant argues that the claims now recite that the composition comprises a structure represented by chemical formula I, but it is still confusing what “phenol derived modified” or tissue derived extracellular matrix” actually means. The chemical structure I may be part of the composition for hydrogel, but it still is confusing especially for “phenol derived modified” or tissue derived extracellular matrix”. The composition for hydrogel may include the structure of Chemical formula I but it is also clearly claimed that there can be more than just Chemical formula I in the “composition for hydrogel”.
The claims encompass anything in addition to the Chemical Formula I. Without knowing what “phenol derived modified” or tissue derived extracellular matrix” actually means the claims are confusing, vague and indefinite..
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655
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