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
The Applicant’s reply filed on 7/14/26 is acknowledged. Claims 1-6, 8-14, 16, 17, 52, 56-59,61, 80, 84, 88-91, 93, 99-102, 104, 106-108, 111, 114-116, and 126 are pending. Claims 52, 56-59, 61, 80, 84, 88-91, 93, 99-102, 104, 106-108, 111, 114-116 and 126 have been withdrawn. Claims 4, 8-10, 12-14, 16 and 17 have been amended. Claims 1-6, 8-14, 16 and 17 are under consideration.
Objections Withdrawn
The objections of claims 4, 13 and 17 are withdrawn in view of the amended claims.
Rejections Withdrawn
The rejections of Claims 8-14 and 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of the amended claim(s).
The rejection of Claims 1-6, 8-14, 16 and 17 under 35 U.S.C. 103 as being obvious over Szereszewski et al. (WO 2021/248236; published 12/16/21, priority 6/8/20; cited in IDS) is withdrawn in view of the statement of common ownership.
Rejections Maintained and New Grounds of Rejections
aim 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 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.
Regarding claim 12, the inclusion of “or more” in line 2 renders the claimed range indefinite because it is not clear if the upper limit is 95%. See MPEP § 2173.05(d). Claims 13 and 14 are rejected as depending from and not clarifying 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 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 1-6, 9-13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Pelling et al. (US 2019/0060520; cited in IDS).
Pelling et al. teach scaffold biomaterials comprising a decellularised plant or fungal tissue from which cellular materials and nucleic acids of the tissue are removed, the decellularised plant or fungal tissue comprising a cellulose- or chitin-based 3-dimensional porous structure (e.g. abstract).
Regarding Claim 1, Pelling et al. teach a scaffold biomaterial in particle form (i.e. comprising structural cells), derived from a plant or fungal tissue from which cellular materials and nucleic acids of the tissue are removed (e.g. paragraph 0128; claim 1), the structural cells being distributed within a hydrogel carrier (e.g. Example 8). Pelling et al. teach that the carrier is a hydrogel, but do not recite that the carrier was derived from a dried or lyophilized form of hydrogel. However, this is a product by process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In the instant case, Pelling et al. disclose the product of claim 1 which comprises a hydrogel carrier and a scaffold biomaterial derived from a plant or fungal tissue from which cellular materials and nucleic acids of the tissue are removed. While there is not a single example comprising each of the claimed components, they among a short list of preferred components and steps. It would have been obvious to one of ordinary skill in the art at the time of the instant invention 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.
Regarding Claims 2 and 3, Pelling et al. teach that the decellularized plant or fungal tissue may be dehydrated and rehydrated (e.g. paragraph 0128).
Regarding Claim 4, Pelling et al. teach that the plant or fungal tissue is decellularized using SDS and CaCl2.(e.g. Claims 3-7).
Regarding Claims 5 and 6, Pelling et al. teach the biomaterial may be dehydrated and ground into a powdered or particle form (e.g. paragraph 0128), but do not teach that the tissue was derived by maceration or mercerization. However, this is a product by process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In the instant case, Pelling et al. disclose the product of claims 5 and 6 which comprise a hydrogel carrier and a scaffold biomaterial comprising structural cells (i.e. in powder or particle form) derived from a plant or fungal tissue from which cellular materials and nucleic acids of the tissue are removed.
Regarding Claim 9, Pelling et al. teach that hydrogel comprises agarose, polyethylene glycol, xanthan, methyl cellulose, alginate, hyaluronan, carboxymethylcellulose, chitosan, polyvinyl alcohol, pectin, and/or dextran (e.g. Example 8).
Regarding Claim 10, Pelling et al. teach the decellularized plant or fungal tissue may be processed to introduce microchannels or moulded (e.g. paragraphs 0006, 0027; Claim 9; Example 8).
Regarding Claim 11, Pelling et al. teach the plant tissue comprises apple tissue, or pear tissue (e.g. paragraph 0029; Claim 10).
Regarding Claim 12, the claimed range is unclear, see 112(b) above. Pelling et al. teach that the biomaterial is in hydrated form (e.g. paragraph 0128, Example 8), but are silent as to the concentration. However, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the biomaterial concentration through routine experimentation to arrive at the concentration of 5-95%, or more, in order to optimize the resulting product.
Regarding Claim 13, Pelling et al. teach a hydrogel comprising alginate or pectin (e.g. paragraph 0292) wherein the filler cross-linked and is rehydrated with water (e.g. paragraph 0128).
Regarding Claim 16, Pelling et al. teach that the biomaterial may be cross-linked and may comprise a functional group (e.g. paragraph 0128, claims 8 and 9).
Regarding Claim 17, Pelling et al. teach the biomaterial comprises structural cells derived from a decellularized plant or fungal tissue, the cells having a decellularized 3-dimensional structure lacking cellular materials and nucleic acids of plant or fungal tissue (e.g. abstract; claim 1). Pelling et al. teach the biomaterial may be dehydrated and ground into a powdered or particle form (e.g. paragraph 0128), but do not teach that the tissue was derived by maceration or mercerization. However, this is a product by process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 8-13, 16 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,642,888 in view of Pelling et al. (US 2019/0060520; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and patented claims recite a composition comprising particles (i.e. single structural cells, groups of structural cells, or both), derived from a plant or fungal tissue, the single structural cells or groups of structural cells having a decellularized 3-dimensional structure lacking cellular materials and nucleic acids of plant or fungal tissue; the single structural cells, groups of structural cells, or both, being distributed within a carrier, the hydrogel carrier.
Claims 1, 3, 8 and 17 are met by patented claims 1, 6 and 8.
Claim 2 is met by patented claim 4.
Claim 4, patented ‘888 does not claim the method of decellularization, however this is met by Pelling. Pelling et al. teach a scaffold biomaterial in particle form (i.e. comprising structural cells), derived from a plant or fungal tissue from which cellular materials and nucleic acids of the tissue are removed (e.g. paragraph 0128; claim 1), the structural cells being distributed within a hydrogel carrier (e.g. Example 8). Pelling et al. teach that the plant or fungal tissue is decellularized using SDS and CaCl2.(e.g. Claims 3-7). 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 the compositions are drawn to substantially similar decellularized plant and fungal biomaterials comprising hydrogels, and one of ordinary skill in the art would have been motivated to seek out an appropriate method to achieve the decellularization of ‘888.
Claim 5 is met by patented claim 23.
Claim 6 is met by patented claim 22.
Claim 9 is met by patented claim 7.
Regarding Claim 10, Pelling et al. teach the decellularized plant or fungal tissue may be processed to introduce microchannels or moulded (e.g. paragraphs 0006, 0027; Claim 9; Example 8).
Claim 11 is met by patented claim 3.
Regarding Claim 12, the claimed range is unclear, see 112(b) above. Pelling et al. teach that the biomaterial is in hydrated form (e.g. paragraph 0128, Example 8), but are silent as to the concentration. However, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the biomaterial concentration through routine experimentation to arrive at the concentration of 5-95%, or more, in order to optimize the resulting product.
Claim 13 is met by patented claim 4.
Regarding Claim 16, Pelling et al. teach that the biomaterial may be cross-linked and may comprise a functional group (e.g. paragraph 0128, claims 8 and 9).
Claims 1-6, 8-13, 16 and 17 are directed to an invention not patentably distinct from claims 1-3, 5, 7-16, 18, 19, 24-27, 29-33, and 104-109 of commonly assigned 12,642,888. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 12,642,888, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Allowable Subject Matter
Claims 8 and 14 are free of the art and are rejected under only 112(b) and nonstatutory double patenting.
Response to Arguments
Applicant's arguments filed 7/14/26 have been fully considered but they are not persuasive. Arguments relevant to the currents grounds of rejection will be addressed below.
Applicant argues that a product-by-process rejection still requires that the applied reference disclose a product that appears to be the same or similar to that of the prior art. Pelling does not disclose a carrier derived from a dehydrated, lyophilized, or freeze-dried hydrogel; rather, Pelling's cellulose is described in "powdered or particle form" or "gel or paste form" (Pelling, [0128]) and, in Example 8, as an inverse mold using gelatin or collagen (Pelling, 11 [0291]-[0292]). Neither are structural cells distributed within a carrier that is itself derived from a dehydrated, lyophilized, or freeze-dried hydrogel.
This is not found persuasive. Pelling et al. teach a scaffold biomaterial in particle form (i.e. comprising structural cells), derived from a plant or fungal tissue from which cellular materials and nucleic acids of the tissue are removed (e.g. paragraph 0128; claim 1), the structural cells being distributed within a hydrogel carrier (e.g. Example 8). The claims are directed to a final product and not to a method of making a product. The claimed carrier is rehydrated (claim 2) which appears to be the same final form as the carriers of Pelling. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). Applicant may demonstrate a structural difference between the claimed carrier and the carrier of Pelling et al.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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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