DETAILED ACTION
Claims 1-8, 10-11, and 26 are pending. Of these, claim 11 is withdrawn as directed to a nonelected invention. Therefore, claims 1-8, 10, and 26 are under consideration on the merits.
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 .
Status of the Rejections
The claim objection is withdrawn in view of the amendment.
The 101 rejection is maintained and expanded to include newly added claim 26.
The 112(b) rejection is withdrawn in part and maintained in part in view of the amendment.
The 103 rejection is maintained and expanded to include newly added claim 26.
The provisional double patenting rejection is maintained and expanded to include newly added claim 26.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 10, and 26 are rejected under 35 U.S.C. 101 as lacking utility (Nature Based Product-Judicial Exception).
Claims 1-8, 10, and 26 are drawn to compositions of matter, which are one of the four categories of statutory subject matter. Therefore, whether the claims lack utility is determined by whether the claims are directed to a judicial exception, and, if so, whether the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, using the Step 2A Prong One, Step 2A Prong Two, and Step 2B analysis. See MPEP 2106.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Claim 1 is directed to a sterile and desiccated biomaterial comprising devitalized differentiated cells having tissue regenerating and/or repairing properties, and a particulate material, wherein the cells and the particulate material are embedded in an extracellular matrix. The skilled artisan would recognize that cells are products of nature, and dependent claim 4 makes it clear that the particulate material also may be a product of nature by reciting that the particulate material may be an organic material such as demineralized bone matrix, gelatin, chitosan, chondroitin sulfate, collagen, elastin, fibrinogen, fibrin, fibronectin, proteoglycans, heparan sulfate proteoglycans, hyaluronic acid, polysaccharides, or laminins. Therefore, the present claims encompass compositions that contain only a mixture of naturally occurring components.
Since the claims read on mixtures of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is an organ or skin from a deceased animal located in an arid desert environment. The skin or other organ would comprise an extracellular matrix comprising collagen. Differentiated cells having regenerating and/or repairing properties would be embedded within the collagen, and any organic material in the matrix would be a “particulate material” as recited by claim 1. For example, dependent claim 4 recites that the particulate material may be an organic material such as elastin, and the skilled artisan would recognize that elastin would be present in the dermis layer of the skin.
While claim 1 further recites additional elements relating to the properties of the biomaterial, i.e., that the biomaterial is sterile and dessicated, and that the differentiated cells are devitalized and have tissue regenerating and/or repairing properties, tissue regenerating and/or repairing abilities are inherent properties of the cells present in body organs, and the cells in an organ or skin from a deceased animal located in an arid environment would become devitalized, sterile, and desiccated over time due to the environmental conditions. Therefore, claim 1 fails to recite any additional elements that would change the structure, function or other characteristics of the individual natural components in any way.
Consequently, claim 1 recites a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Here, the language of claim 1 is limited to the recitation of structural elements of the biomaterial, and fails to recite any additional elements relating to a practical application of the exception. Therefore, claim 1 is directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. Here, claim 1 does not recite any additional elements beyond the structural elements and their properties as discussed above. Therefore, claim 1 does not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claim as a whole does not amount to significantly more than the judicial exception.
Conclusion: Claim 1 which encompasses a composition that may comprise only a mixture of natural products, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claim 1 is directed toward a judicial exception under 35 USC 101. Additionally, dependent claims 2-8, 10, and 26 do not recite any further element which would be considered to provide ‘significantly more’ than the judicial exception.’ Consequently, claims 1-8 and 10 prima facie lack utility under 35 USC 101.
Response to Applicant’s Arguments
Applicant argues that while the rejection asserts that a sterile, dessicated, devitalized biomaterial would occur over time due to environmental conditions from a deceased animal located in an arid desert, there is nothing in the claim suggesting a deceased animal or desert environment.
In response, this is not persuasive because whether the claims are unpatentable under 35 USC 101 as being drawn to a nature-based product turns on whether the language of the claims encompasses a nature-based product: the claims needn’t be limited solely to a nature based product to run afoul of 101.
Applicant also argues that the rejection does not support the statement that the differentiated cells having regenerating and/or repairing properties would be embedded within the collagen, and that the rejection does not address whether or not the arid desert environment could be so severe as to destroy the differentiated cells. Applicant argues that it is not sufficient that the claimed elements may occur in an arid environment, but rather that they must always occur in order to be inherent, citing to Ex parte Levy.
In response, Ex parte Levy is not dispositive of the issues in the rejection because the holding in this case is with respect to a 102 rejection, and not a 101 rejection. Moreover, it is not necessary that each and every case of a deceased animal located in an arid desert inherently would result in a sterile, dessicated, devitalized biomaterial over time that would be within the scope of the claims. Rather, even a single instance of such an occurrence means that the claims read on a nature-based product, and the skilled artisan reasonably would have expected that the differentiated cells having regenerating and/or repairing properties would be embedded within the collagen of a dessicated dead animal because collagen is the primary structural protein that is found in skin and connective tissue such that a significant amount of cellular material would be embedded in the collagen. Additionally, even if an arid environment would eventually destroy differentiated cells, the process of destruction would take time, and prior to the time period over which cellular destruction would occur, a biomaterial within the scope of the claims would exist. The Office notes that claim 1 does not specify a degree of viability of the cells and claim 26 specifies that no more than 1% of the cells are viable.
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 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 4 recites “an organic material, including” followed by a list of species, as well as reciting “a ceramic material, including” followed by a list of species, “a polymer, including” followed by a list of species, and “a gel, including” followed by a list of species and “fumarate-based polymers such as, for example.” In each case, the recitation of “including” and the recitation of “such as, for example” renders the metes and bounds of the claim unclear, because it is unknown if “including” is intended to signal that the list of species following “including” is exhaustive such that the species of ceramic material, polymer, and gel must be selected from one of the species that is explicitly recited. Clarification is required.
Response to Applicant’s Arguments
Applicant argues that the claims have been amended based upon the Examiner’s suggestions, but claim 4 continues to recite the indefinite limitations described above in the rejection. Therefore, the rejection as to claim 4 is maintained.
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 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 1-8, 10, and 26 are rejected under 35 U.S.C. 103 as unpatentable over Egusa (US Pat. Pub. 2016/0287753 (published 10.6.2016); of record in IDS) in view of Kiminami et al. (published 6.23.2016)(US Pat. Pub. 2016/0175481).
As to claims 1-8,10, and 26, Egusa discloses a bone regeneration biomaterial comprising inactivated (“devitalized”) stem cells (i.e., the elected species of “cells” of claims 1-2) and mineral particles such as calcium phosphate particles (a “particulate material” of claims 1 and 4) embedded in an extracellular matrix (paragraphs 23 and 84). The stem cells may be sterilized (paragraph 105). The stem cells are inactivated via lyophilization (“freeze-drying” of claim 10 which will result in dessication of the biomaterial as recited by claim 1 (paragraph 23, step 12 and paragraph 105).
As to claims 1-8,10, and 26, Equsa does not further expressly disclose that the particulate material comprises the elected species of particulate of claims 1 and 4, i.e., gelatin. Nor does Equsa expressly teach that the number of viable cells is within the range of claims 3 and 26, or that the biomaterial comprises an altered factors content as recited by claim 5 such as altered growth factors and/or transcription factors (claim 6) such as one of the factors recited by claim 7 or RNA content as recited by claim 8.
Kiminami discloses a bone regeneration kit comprising a bone regeneration material such as a calcium phosphate and particles comprising a bioabsorbable polymer such as gelatin (paragraphs 1, 19, 22, 40). Kiminami teaches that the use of a combination of a particle comprising the bioabsorbable polymer and a particle comprising a calcium salt provides a material that provides anti-washout properties after filling even when in contact with water such as blood or other biological fluids (paragraph 18).
As to claims 1-8,10, and 26, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Egusa biomaterial by incorporating a gelatin particulate into the biomaterial as an additional particulate to the mineral particulate, because Kiminami teaches that combining a gelatin particle with a calcium mineral particle in a bone regeneration material results in an improved material that provides anti-washout properties after filling, such that the skilled artisan reasonably would have recognized that incorporating a gelatin particle into the Kiminami bone regeneration material would be advantageous. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
The modified prior art composition as discussed above will comprise the viable cell count of claims 3 and 26 and an altered factors content as recited by claim 5 such as altered growth factors and/or transcription factors (claim 6) such as one of the factors recited by claim 7 or RNA content as recited by claim 8, because it comprises the same ingredients recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Response to Applicant’s Arguments
Applicant argues that Egala teaches cell aggregates, while Kiminami teaches a bone generation material kit comprising particles with inositol phosphate while the present claims do not claim inositol phosphate. Applicant concludes that neither document supports a rejection predicated on obviousness except based upon the use of excessive hindsight.
In response, these arguments are not persuasive because the adequacy of the rationale necessary to support the present obviousness rejection depends upon a conclusion that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Here, while Applicant points to specific elements of the inventions disclosed by Egala and Kiminami, Applicant has not articulated why these disclosures by the cited art undermine the rationale underlying the present rejection, nor pointed to any elements of the claimed invention that are not disclosed or suggested by the cited art, nor articulated any argument as to why there would not have been a reasonable expectation of success in combining the cited art as suggested by the rejection.
Applicant’s assertion that the rejection relies upon excessive hindsight is not persuasive because it is conclusory in nature as it is not supported by any argumentation as to what portion’s of Applicant’s disclosure have allegedly been used improperly to remedy an alleged deficiency in the cited art.
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 § 2146 et seq. 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 1-8,10, and 26 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of U.S. Pat. Appl. No. 17/273,143 and in view of Egusa (US Pat. Pub. 2016/0287753) where indicated below.
The teachings of Egusa are relied upon as discussed above.
The reference claims recite a biomaterial comprising stem cells and gelatin particles in an extracellular matrix.
Although the reference claims do not recite that the biomaterial is sterile and desiccated such that it comprises devitalized cells, it would have been prima facie obvious to use sterile and desiccated cells in light of Egusa’s suggestion that a biomaterial comprising stem cells and gelatin particulate material embedded in an extracellular matrix can be lyophilized and sterilized. The resulting composition will possess a number of viable cells is within the ranges of claims 3 and 26, and the biomaterial will comprise an altered factors content as recited by claim 5 such as altered growth factors and/or transcription factors (claim 6) such as one of the factors recited by claim 7 or RNA content as recited by claim 8, because it comprises the same ingredients recited by the claims and a product cannot be separated from its properties.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of 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 as of 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.
Response to Applicant’s Arguments
Applicant did not submit any arguments against the double patenting rejection, which is therefore maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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 GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600