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 .
Claims Status
Claims 1-15 are pending.
Priority
PNG
media_image1.png
114
1130
media_image1.png
Greyscale
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 parent Application No. 16617740, filed on 11/27/2019. This CIP introduces new subject matter that is not present in the parent Application. For example, claim 1 introduces the concept of “at least three freeze/thaw cycles” and step (f) decontaminating the cartilage graft scaffold. The parent application does not appear to teach step (f) at all and teaches “alternately kept at -20 °C and room temperature for 1 hour respectively, twice frozen dryly” [0086] and “the cartilage samples are kept at about -20 °C and room temperature for about 1 hour respectively, several times frozen dryly” [0072]. The term “twice” refers to two cycles and the term “several”, while not an exact number indicates a limited number of cycles. In contrast, the term “at least three freeze/thaw cycles” is open ended and includes 3 and many more cycles without limit. All dependent claims depend directly or indirectly from claim 1. Accordingly, step (f) and “at least three freeze/thaw cycles” are new concepts and the effective filing date for the application of prior art against the claimed subject matter is 04/16/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/3/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 introduces the acronym “GAG”. It is customary to provide the term represented by the acronym first. In this case, it is “glycosaminoglycan”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 ends with 2 periods:
PNG
media_image2.png
122
1130
media_image2.png
Greyscale
. Appropriate correction is required.
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.
Claims 12, 14 and 15 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.
Claim 12 recites the limitation "the step (g)" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no step (g) in claim 1. Correction is required.
Claim 14 recites the limitation "the step (h)" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no step (h) in claim 1. Correction is required.
Claim 15 recites the limitation "step (g)" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no step (g) in claims 1, 11 or 13. Correction is required. Step (g) is found in claim 12.
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, 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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Redl et al. (WO2018220047; published 06 December 2018) and Vangsness, C.T. (Chapter 9 Allografts in Noyes’ Knee Disorders: Surgery, Rehabilitation, Clinical Outcomes. 2020 June 22: pages 240-244).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims:
PNG
media_image3.png
544
1136
media_image3.png
Greyscale
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a tissue engineering research scientist, as is the case here, then one can assume comfortably that such an educated artisan will have comprehensive knowledge of tissue engineering biomaterials for implantation as well as current good tissue practice (CGTP) to prevent the introduction, transmission or spread of communicable diseases and draw conventional ideas from tissue engineering principles to design 3D platforms for cell attachment, proliferation and differentiation upon implantation to produce new tissue— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claim 1, Redl et al. teach in claims 16-20:
PNG
media_image4.png
728
1334
media_image4.png
Greyscale
Redl et al. also teach incising a plurality of notches after decellularizing and/or devitalizing the cartilage biomaterial [0026]:
PNG
media_image5.png
258
1052
media_image5.png
Greyscale
Regarding steps (a)-(e), Redl et al. further teach:
PNG
media_image6.png
356
1370
media_image6.png
Greyscale
The enzyme solution serves to deplete GAG of step (d). Redl et al. teach GAG-depleted cartilage graft scaffold [0071]. See also claim 15:
PNG
media_image7.png
120
1304
media_image7.png
Greyscale
The sodium hydroxide is a basic solution.
PNG
media_image8.png
496
1364
media_image8.png
Greyscale
PNG
media_image9.png
182
1384
media_image9.png
Greyscale
Redl et al. also teach that the freeze/thaw can be performed several times [0072]. Accordingly, the artisan performing the method of Redl et al. obtains a cartilage graft scaffold biomaterial comprising a plurality of notches in the form of lamellae or grid. (See also Figures 1-6 and 8).
Regarding claims 2-6, Redl et al. teach:
PNG
media_image10.png
778
1384
media_image10.png
Greyscale
See also claims 4-6.
Regarding claims 7-10, Redl et al. teach:
PNG
media_image11.png
366
1374
media_image11.png
Greyscale
See also claims 7-8.
Regarding claim 11, Redl et al. teach:
PNG
media_image12.png
260
1380
media_image12.png
Greyscale
See also claim 9.
Regarding claim 12-15, Redl et al. teach:
PNG
media_image13.png
434
1364
media_image13.png
Greyscale
Thus, step (g) is taught by Redl et al.
The cartilage graft scaffold is implanted into a subject in need thereof [0079-0080]. Also see claims 21-22. Redl et al. implanted osteochondral plugs into a mouse ([0038]; Figure 7). Thus, step (h) is taught by Redl et al.
Regarding claim 1 step (f), Vangsness teaches that there are two ways to transmit disease with allograft tissue. One is by direct transmission of the infection from an infected donor and the other is through tissue handling, processing and packaging (Page 241, right column critical points TISSUE PROCESSING). Vangsness teaches current sterilization methods (Table 9-1, page 243) and states that: “The last step of preparation before tissues are distributed for implantation involves packaging and terminal sterilization… To remove concerns about this contamination, terminal sterilization is the final processing step to prepare tissues for shipping in their prepared
packages.” (Page 342, right column Step Three: Packaging and Terminal Sterilization).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Redl et al. is that Redl et al. do not expressly teach providing a plurality of notches in the form of lamellae or grids (step (b)) after devitalizing (step (a)) and before decellularizing (step (c)) and finally decontaminating the cartilage graft scaffold (step (f)). This deficiency in Redl et al. is cured by the teachings of Vangsness.
1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a plurality of notches in the form of lamellae or grids (step (b)) after devitalizing (step (a)) and before decellularizing (step (c)) and finally decontaminating the cartilage graft scaffold (step (f))decontaminate the cartilage graft scaffold of Redl et al., as suggested by Vangsness, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because the order of performing process steps is prima facie obvious in the absence of new or unexpected results (see MPEP 2144.04 IV: “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results). Redl et al. teach steps of devitalizing, decellularizing and notching the biomaterial cartilage graft scaffold. Thus, providing the plurality of notches after devitalizing and before decellularizing is obvious to the ordinary artisan as ultimately the process steps produce the same product.1 With regard to step (f), there is a concern about contamination of the graft prior to implantation into a subject as taught by Vangsness. The solution taught by Vangsness is to decontaminate the graft via terminal sterilization as a last step. Thus, it is desirable to decontaminate the cartilage graft scaffold of Redl et al. prior to implantation into a patient to avoid infecting the patient. The ordinary artisan would do so with a reasonable expectation of success.
2. The difference between the instant application and Redl et al. as modified by Vangsness is that Redl et al. as modified by Vangsness do not expressly teach at least three freeze/thaw cycles of step (a).
2. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform at least three freeze/thaw cycles of step (a) in the method of Redl et al. as modified by Vangsness, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Redl et al. teach: “alternately kept at -20 °C and room temperature for 1 hour respectively, twice frozen dryly” [0086] and “the cartilage samples are kept at about -20 °C and room temperature for about 1 hour respectively, several times frozen dryly” [0072]. The term “twice” refers to two cycles and a reasonable interpretation of the term “several” is that it is not an exact number but indicates a limited number of cycles greater than 2 but less than 10, which would overlap with the claimed limitation of at least three. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Consequently, conducting at least three freeze/thaw cycles is obvious in the absence of unexpected results.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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, Brian Y Kwon can be reached at 571-272-0581. 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.
/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 The specification teaches notching the scaffold first first followed by devitalization and decellularization [00101-00102, 00111-00112].
Prosecution Insights