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 .
DETAILED ACTION
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1619, Examiner Nicole Babson.
Claims 1-19 are pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-9, drawn to a scaffold, and the species of a) atelocollagen; b) poly(lactide-co-glycolide) (PLGA); and c) rotator cuff tendinopathy, in the reply filed on 8/31/26 is acknowledged.
The Examiner is withdrawing the requirement for an election of species, and search will be expanded to the full scope of species (a)-(c).
The Examiner is maintaining the requirement for an election of Invention.
Claims 10-19 are withdrawn as being drawn to a nonelected invention.
Claims 1-9 are under consideration.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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.
Claim 6 is 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.
Claim 6 recites an improper Markush group in lines 2 and 9. A Markush-type claim recites alternatives in a format such as “selected from the group consisting of A, B, and C”. It is improper to use the term “a group” instead of “the group” Ex parteDotter, 12 USPQ 382 (Bd. App. 1931) (see MPEP 2173.05 and 803.02).
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 of this title, 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 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 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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable Murray (US 2020/0171203), as evidenced by Ethicon (“VICRYL™ polyglactin 910” 2023), in view of Zhao (US 2011/0262489).
Murray teaches methods and devices for repair of a torn or ruptured ligament using a scaffold device (e.g. abstract). Murray teaches a scaffold for repair of a torn or ruptured ligament (i.e. treatment of tendon or ligament diseases as defined in claim 6), comprising:
a porous hyaluronic acid scaffold (e.g. paragraph 0045);
collagen immersed in pores of the porous hyaluronic acid scaffold (e.g. paragraphs 0062, 0048); and
a bioabsorbable suture secured through the scaffold (i.e. bioabsorbable copolymer fiber adhered on the first surface of the porous hyaluronic acid scaffold) (e.g. paragraphs 0014, 0050).
Murray does not teach that the scaffold is a cryogel. This is made up for by the teachings of Zhao.
Zhao teaches porous hyaluronic acid cryogels (e.g. abstract; Claim 22). Zhao teaches that the cryogels can be used in cosmetic surgery, for tissue augmentation, and tissue repair and can be used as carriers for pharmaceuticals or other bioactive substances for controlled drug delivery (e.g. paragraph 0043, 0112, 0133, 0144). Zhao teaches that there is a long felt need for an ideal chemical modification method for the modification of hyaluronic acid, and to produce an ideal biodegradable scaffold for tissue engineering to overcome the previous problems (e.g. paragraphs 0011-0022). Zhao teaches that cryogels are a new class of materials which are mechanically strong and have a highly porous structure and having a broad variety of morphologies (e.g. paragraphs 0023-0026).
Regarding Claims 1 and 6, it would have been obvious to one of ordinary skill in the art at the time of filing to select the hyaluronic acid cryogel of Zhao for use in the scaffolds of Murray. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of Murray and Zhao disclose porous scaffolds of hyaluronic acid for tissue repair, one of ordinary skill would have been motivated in order to provide the benefits of a mechanically strong structure with a highly porous structure, as taught by Zhao.
Regarding Claims 2 and 3, Murray teach that the collagen may be type I collagen and may be manufactured from a patient’s own skin (i.e. human collagen) (e.g. paragraph 0048 and 0070).
Regarding Claims 4 and 5, Murray teaches that the sutures may be made of VICRYL™ polyglactin 910 (e.g. paragraph 0050), which as evidenced by Ethicon is absorbable and comprises a copolymer made from 90% glycolide and 10% L-lactide (e.g. pages 1-2).
Regarding Claims 7-9, the claims are directed to an intended use and outcome of using a claimed product and do not recite any additional ingredients or structure. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case product of Murray and Zhao comprises the claimed components for repair of a torn or ruptured ligament, therefore the claim has been met.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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