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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 12/20/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/15/2025, 09/12/2024 and 12/20/2022 are being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 01/12/2026 is acknowledged.
Claims 33-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2026.
Claims 1-3, 11, 13, 15, 17, 19, 21-28 are being examined on the merits.
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 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 3, it is unclear how the first two formulations recited result in different complex modulus plateau? They appear to be the same compositions. Clarification is requested.
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 1-3, 11, 13, 15, 17, 19, 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Sun ‘272et. al. (From IDS 12/20/22, US20190070272A1) hereinafter Sun ‘272Sun et. al. (From IDS 12/20/22, US20060073592A1), hereinafter Sun.
Regarding claims 1, Sun ‘272 teaches of a decellularized tendon matrix composition such as enzyme-activated acellular tissue matrices that facilitate regrowth of the damaged tissue such as skin, cartilage and tendons (see abstract and para. 0032).
Sun ‘272 teaches using different matrix metalloproteinases MMPs and that the particular MMP selected may depend on the matrikines desired upon degradation of extracellular matrix or the particular cellular process to be affected (see 0042). “MMP-mediated degradation of the extracellular matrix results in the liberation of matrikines, bioactive peptides with the ability to regulate cellular activity. Matrikines are known to modulate aspects of cellular activity, including cell proliferation, adhesion, migration, and apoptosis. Matrikines have also been implicated in protein synthesis and degradation” (see 0025). “In various embodiments of the present disclosure, MMPs are loaded into a tissue matrix to create a tissue matrix composition with enhanced capabilities for tissue regeneration. A deactivating agent is used to inhibit MMP activity until the tissue matrix composition is placed into the body, impeding degradation of extracellular matrix proteins until the appropriate time. Once placed inside the body, the MMPs are automatically reactivated, resulting in the release of matrikines and the subsequent enhancement of the healing process. In short, by incorporating specific matrix-degrading enzymes into tissue matrices, one can affect matrix degradation kinetics to facilitate active healing, tissue integration, and tissue regeneration” (see 0026).
Regarding claims 26 and 28, Sun ‘272 teaches “after the decellularization process, the tissue sample is washed thoroughly with saline. In some exemplary embodiments, e.g., when xenogenic material is used, the decellularized tissue is treated overnight at room temperature with a deoxyribonuclease (DNase) solution” (see 0037).
Regarding claims 27 and 28, Sun ‘272 teaches the MMPs can include collagenases (see 0024) and teaches lyophilizing the matrix tissue (see claim 17), and hydrating (see claim 18), which in the broadest reasonable interpretation is reconstitute because the definition for reconstitute is to constitute again or a new to restore to a former condition by adding water.
Sun ‘272 does not specifically teach that when formulated in a formulation comprising an amount of fluid and about 1 g of composition, the formulation has a complex modulus plateau between about 103 Pa and about 106.5 Pa.
Regarding claims 1-3, 11, 13, 19, Sun Sun teaches of acellular tissue matrices (ATM) and that it is understood that the ATM can be produced from any collagen-containing soft tissue and muscular skeleton (e.g., tendons) as long as the above-described properties are retained by the matrix (see 0036), and wherein they can be formulated in varying concentrations with fluid. For example, Sun teaches “the final product is a powder (usually white or off-white) generally having a particle size of about 1 micron to about 900 microns, about 30 microns to about 750 microns, or about 150 to about 300 microns. The material is readily rehydrated by suspension in normal saline or any other suitable rehydrating agent known in the art”. “If suspended at a high concentration (e.g., at about 600 mg/ml), the particulate ATM can form a “putty”, and if suspended at a somewhat lower concentration (e.g., about 330 mg/ml), it can form a “paste”. Such putties and pastes can conveniently be packed into, for example, holes, gaps, or spaces of any shape in tissues and organs so as to substantially fill such holes, gaps, or spaces” (see 0057). Here Sunteaches rehydrating the acellular material in fluid at about 600mg/ml or 1 g/~1.677 ml and teaches rehydrating the acellular material in fluid at about 330 mg/ml or 1 g/~3.030 ml.
Regarding claim 24, Sun also teaches that the water-replacing agent can be PBS (see 0062) and teaches washing the product (see 0057),
Regarding claim 25, Sun teaches the tissues to be human or non-human (see claims 11-14 and 0004).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to create the instant invention given the relied upon art. Sun ‘272 teaches of decellularized tendon matrices digested with MMP and Sun teaches of formulating acellular tissue matrices wherein fluid is used in amounts equivalent to the instantly claimed parameters with water-replacing agents and which can be stored for extended periods of time at ambient temperatures without loss of structural or functional integrity (see 0003). Although the art is silent on testing the composition for storage modulus, loss modulus, complex modulus, phase angle and/or yield stress, these tests can be performed by any skilled artisan without any undue experimentation and with the expectation that the composition would meet the instantly claimed parameter requirements. In this case the prior art’s composition would appear to be similar in nature if not identical to what the applicant is claiming, because the prior art teaches of decellularized tendon matrix comprising matrix metalloproteinase digested tendon tissue in formulations comprising an amount of fluid 1 ml and about 1 g of composition. Optimizing to the amounts not necessarily taught in the art such formulating in 5 ml and 7 ml of fluid, would have been obvious optimizations for creating improved modified formulations which could facilitate repair and regrowth of damaged tissues as discussed in the prior art.
Please note, since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655