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 .
Applicants’ response of 8/26/2025 has been received and entered into the application file. Claims 1-20 remain pending.
Election/Restrictions
Applicant’s confirmed their election of Group I, claims 1-9 and 12-20. The election is made with traverse. The traverse is on the grounds that the office has not shown proper patentable distinction between a “product” and process of using said product, because the claims of Group I are not product claims, but rather are directed to processes for increasing a proportion of CD56 positive cells in a skeletal muscle tissue sample.
This is not found persuasive because Group I contains claims directed to methods of treating a skeletal muscle tissue to increase the proportion of CD56+ cells therein, cell populations produced by said method, methods of making grafts using said cell populations, and the grafts thereby made. Claims directed to process of making a product and the product thereby made were kept in a single group. Overall, the group is characterized by the product made. The restriction properly showed how the product of Group I can be used in an alternative process. If one wished to compare the methods of making of Group I to the methods of treatment of Group II, then they would be related as related, but distinct methods, having no overlapping steps and distinct outcomes. Restriction is maintained and made final.
Claim Interpretation
The amended claims use the transitional phrase “consisting essentially of” when defining the composition of the preservation solution. Per the MPEP at 2111.03, the transitional phrases "comprising," "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. See In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). For the purposes of examination, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See PPG Industries v. Guardian Industries 156 F.3d 1351, 1354, 38 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). A review of the specification provides no clear indication of what constitutes a material change in the preservation solution. In fact, the disclosure states that the preservation solution is ‘not particularly limited as long as the CD56 positive cells in the tissue can survive’. Numerous examples, including physiological buffers (including PBS and HBSS), cell culture solutions, tissue preservation solutions, organ preservation solutions and more are disclosed. The specification states the saccharide, amino acid, vitamin, electrolytes, growth factors and additive content of any solution may be manipulated (See ¶0032 of the PGPub). As such, the specification does not disclose basic and novel characteristics of the preservation solution, and thus the transitional phrase “consisting essentially of” is being construed as “comprising”.
Claim 1 is drawn to a method for increasing a proportion of CD56+ cells in skeletal muscle tissue sample. The only required step is soaking the skeletal muscle tissue sample in a preservation solution for 12-140 hrs. The preservation solution is interpreted as comprising HBSS and glucose at a concentration of 1.6 mg/mL. Due to use of the open transitional phrase “comprising”, the method can include additional, unrecited steps. The totality of the method must result in increased proportion of CD56+ cells in the skeletal muscle sample compared to starting tissue (e.g. native tissue sample). Note: the increased proportion of CD56+ cells need not be a direct result of the soaking step. However, it is noted that the specification teaches that, due to the location of CD56+ cells within muscle cells, the CD56+ cells have a survival advantage when subject to a soaking step (See ¶0035 & ¶0117). Thus soaking is considered to inherently result in destruction of more CD56- cells than CD56+ cells, and thus increase the overall proportion of CD56+ cells in a muscle tissue sample.
Claim 2 further limits the method of parent claim 1 by requiring the soaking step to result in reduction of non-CD56+ cells to less than 20%. This is functional limitation that effectively limits the method to embodiments wherein the soaking step will reduce non-CD56+ cells to less than 20%. This encompasses embodiments where the non-CD56+ cells are 0%.
Claim 3 further limits the method of parent claim 1 by requiring the soaking step to result in swelling of the muscle tissue sample to a degree of 1.2 or more. This is functional limitation that effectively limits the method to embodiments wherein the soaking step will achieve swelling to a degree of 1.2 or more.
Claim 5 is interpreted as involving the identical steps as claim 2. However, claim 5 further requires that the resulting cell population has a ratio of CD56+ cells to non-CD56+ cells of 80% or more. The phrase “ratio of CD56+ cells to non-CD56+ cells” is interpreted as meaning both CD56+ cells and non-CD56+ cells are present (otherwise there is no ratio, it is just a pure population of CD56+ cells). The ratio being 80% or more is interpreted as meaning 80:20 or greater, but at least some non-CD56+ cells must be present (i.e. ratio cannot be 100:0). There is nothing in the claim that requires separation of cells from the sampled skeletal muscle tissue. Thus the cell population covers the cells in the soaked muscle tissue sample.
Though claim 5 does not require isolation of the cells, in its broadest reasonable interpretation, claim 5 also covers embodiments where the cells are isolated from the soaked tissue to produce an isolated cell population having a ratio of CD56+ cells to non-CD56+ cells of 80:20 or greater, but at least some non-CD56+ cells must be present (i.e. ratio cannot be 100:0).
Claim 7 uses product-by-process language. Product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore if the product, as claimed, is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, claim 7 claims a cell population obtained by the method according to claim 5. As discussed above, the method of claim 5 will result in (i) a skeletal muscle tissue sample modified to comprise an increased proportion of CD56+ cells, wherein the increased proportion is at least 80% CD56+ cells, but at least some non-CD56+ cells remain, or (ii) an isolated cell population comprising at least 80% CD56+ cells, and at least some non-CD56+ cells.
Claim 8 is interpreted as being drawn to a method of producing a graft comprising culturing the cell population of claim 7 on a culture substrate for 1-72 hrs at about 0oC to about 60oC. It is noted that mammalian cells die quickly at 40oC and over (See Freshney, “Temperature” Pg. 92). Thus, the scope of claim 8 covers both culturing the cell population of claim 7 under conditions that will yield a living tissue graft, as well as culturing the cell population of claim 7 under conditions that will result in complete cell death. The cell proportions are not necessarily maintained during the culture.
Claim 9 uses product-by-process language. As above, product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. In the instant case, the method of claim 8 covers production of a tissue comprising living cells, wherein at least some of the cells are CD56+, as well as a composition consisting of dead cells, wherein at least some of the cells are CD56+ cells. Thus, claim 9 covers a tissue comprising living cells, wherein at least some of the cells are CD56+, as well as a composition consisting of dead cells, wherein at least some of the cells are CD56+ cells.
Claim 12 requires a step of increasing the proportion of CD56+ cells in a skeletal muscle tissue sample, comprising obtaining a skeletal muscle sample comprising CD56+ and non-CD56+ cells; then soaking the skeletal muscle tissue in a preservation solution for 5 to 672 hrs to increase the proportion of CD56+ cells. The preservation solution is interpreted as comprising HBSS and glucose at a concentration of 1.6 mg/mL. The method is limited to embodiments wherein the soaking step results in increasing the proportion of the CD56+ cells in the skeletal muscle sample. It is noted that the specification teaches that, due to the location of CD56+ cells within muscle cells, the CD56+ cells have a survival advantage when subject to a soaking step (See ¶0035 & ¶0117). Thus soaking is considered to inherently result in destruction of more CD56- cells than CD56+ cells, and thus increase the overall proportion of CD56+ cells in the muscle tissue sample. Finally, the method requires a step of separating the CD56+ cells from the skeletal muscle tissue following the soaking step. The end result will be a cell population comprising CD56+ cells.
Claims 13 and 14 further limits the method of parent claim 12 by requiring the soaking step to result in increasing the proportion of CD56+ cells to 80% or more (claim 13), or reduction of non-CD56+ cells to 20% or less (claim 14). These limitations have the same scope. They are functional limitation that effectively limits the soaking step to embodiments which will increase the CD56+ cells to at least 80% and/or reduce non-CD56+ cells to 20% or less.
Claim 17 is the same as claim 12, except claim 17 further limits the soaking step to result in swelling of the muscle tissue sample to a degree of 1.05 or more. This is functional limitation that effectively limits the soaking step to embodiments which will achieve swelling to a degree of 1.05 or more.
Claim 18 further limits the method of parent claim 17 by requiring the method result in increase of CD56+ cells to 80% or more. This is functional limitation that effectively limits the soaking step to embodiments which will increase CD56+ cells to 80% or more.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 5-9 under 35 USC 112(b):
The amendment to claims 5 and 7 to remove the term “high” is effective to overcome the rejections. The rejections are withdrawn.
RE: Rejection of claims 7 and 9 under 35 USC 101:
Applicants assert the amendment to claim 7 render the claim markedly different from naturally occurring skeletal muscle tissue (as characterized by McKay et al).
This argument, in light of claim amendments, is found persuasive. Comparing the claim to naturally occurring skeletal muscle tissue, naturally occurring skeletal muscle tissue does not have an increased proportion of CD56+ cells, rather it has a native level of CD56+ cells. The product-by-process steps do affect the final structure in a meaningful way that makes the claimed composition markedly different from the closest naturally occurring counterpart.
However, a modified rejection is made to address the amended claim scope.
RE: Rejection of claims 7-9 under 35 USC 102(a)(1) over Marksteiner et al:
Applicants have traversed the rejection of record on the grounds that Marksteiner et al does not teach or suggest the details of the method of claim 1.
The argument has been fully considered, but is not found persuasive. Claim 7 is a product-by-process claim. Claim 7 is interpreted as (i) a skeletal muscle tissue sample modified to comprise an increased proportion of CD56+ cells, wherein the increased proportion is at least 80% CD56+ cells, but at least some non-CD56+ cells remain, or (ii) an isolated cell population comprising at least 80% CD56+ cells, and at least some non-CD56+ cells. Marksteiner et al disclose a cell population comprising 98% CD56+ SMDCs, meaning that the cell population thus comprises 2% non-CD56 cells. Though made by a different process, the cell populations of Marksteiner et al has the same composition as the cell population of current claim 7, and thus properly anticipates claim 7. The rejection of claim 7 is maintained.
The rejection has been modified to address amended claims 8 and 9.
RE: Rejection of claims 1-9 and 12*-20 under 35 USC 102(a)(1) over Vilquin et al:
The rejection heading previously stated claims 1-9 and 16-20 were rejected, however, claims 12-15 were also specifically addressed.
Applicants have traversed the rejection of record on the grounds that neither Vilquin et al does not teach or suggest the details of the method of claim 1.
The argument has been fully considered, but is not found persuasive against the rejection of claim 7. Claim 7 is a product-by-process claim. Claim 7 is interpreted as (i) a skeletal muscle tissue sample modified to comprise an increased proportion of CD56+ cells, wherein the increased proportion is at least 80% CD56+ cells, but at least some non-CD56+ cells remain, or (ii) an isolated cell population comprising at least 80% CD56+ cells, and at least some non-CD56+ cells. Marksteiner et al disclose a cell population comprising 98% CD56+ SMDCs, meaning that the cell population thus comprises 2% non-CD56 cells. Though made by a different process, the cell populations of Vilquin et al has the same composition as the cell population of current claim 7, and thus properly anticipates claim 7. The rejection of claim 7 is maintained.
The rejection has been modified to address amended claim 9.
The amendment to claims 1, 8, 12 and 17 are effective to differentiate over Vilquin et al. Vilquin et al teaches storing the muscle tissue sample in equilibrated saline, which is not the same as HBSS with 1.6 mg/mL glucose. There is insufficient evidence in the prior art to establish that equilibrated saline and HBSS with 1.6 mg/mL glucose would have the same effect on myoblasts and fibroblasts within a skeletal muscle sample. The rejection of claims 1-6, 8 and 12-20 are withdrawn
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.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature judicial exception without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Regarding claim 7: For reasons set forth above (Claim Interpretation), the claim is directed is interpreted as covering a (i) a skeletal muscle tissue sample modified to comprise an increased proportion of CD56+ cells, wherein the increased proportion is at least 80% CD56+ cells, but at least some non-CD56+ cells remain, or (ii) an isolated cell population comprising at least 80% CD56+ cells, and at least some non-CD56+ cells. This rejection is made over embodiment (ii) an isolated cell population comprising at least 80% CD56+ cells and at least some non-CD56+ cells.
The claim is directed to a composition, which is a statutory category of invention (Step 1: YES).
Each of CD56+ and non-CD56+ cells from skeletal muscle tissue, individually, are nature-based products (Both CD56+ and non-CD56+ cells from skeletal muscle tissue are naturally occurring (See, e.g. Uezumi et al, who teach skeletal muscle contains both CD56+ cells and PDGFRα+/CD56- cells (See Fig. 1A))).
When a claimed composition includes nature-based products, further analysis is taken to determine if the claimed composition recites a nature-based product judicial exception by comparing the claimed composition to the closest naturally occurring counterpart to determine if the claimed composition has markedly different characteristics than the counterpart. In the instant case, the cell population, as a whole (i.e. in combination), does not clearly exist in nature, thus there is no naturally occurring counterpart. However, simply because a combination of nature-based products does not exist in nature does not mean the claim is not directed to a product of nature judicial exception. When a claim is to a combination of multiple nature-based products and the composition as a whole (i.e. in combination) does not exist in nature, comparison is made between each of the individual nature-based products in the composition and their respective naturally occurring counterparts. In the instant case, the claimed cell population can consist of 80% CD56+ cells and 20% PDGFRα+/CD56- cells. Each of CD56+ cells and PDGFRα+/CD56- cells are naturally occurring cells that exist in nature (See Uezumi et al, id). There is no indication or evidence in the specification or prior art that combining these individual natural products together results in any structural, chemical or functional change to any one or more of the individual products; thus, even in combination none of the individually recited components are markedly different from their respective naturally occurring counterparts. The recited concentrations of cells does not have any effect on their properties in the composition. When multiple nature-based products are provided in combination, but the combination does not impart any change to the individual components (i.e. the individual components are not incorporated into a higher ordered structure, or physically or chemically changed due to the combination), then the nature-based products must be considered independently from one another. Therefore, while the composition as a whole does not exist in nature, the composition includes two nature-based product which are not markedly different from their individual respective naturally occurring counterparts (CD56+ cells and PDGFRα+/CD56- cells). Each of the nature-based products are thus considered to be products of nature, and thus the claim is considered directed to at least one product of nature judicial exception (Step 2A, prong 1: YES).
The claim does not integrate the product into a practical application because the claim is to the cell population, per se, not a method of use. (Step 2A, Prong 2: NO).
The claim does not recite any elements in addition to the judicial exception, so there are no additional elements that add significantly more to the judicial exception (Step 2B: NO).
The claim is patent ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 has been amended to require culturing the cell population on a culture substrate for 1 hr to 72 hrs at a temperature ranging from about 0o to about 600C. This is new matter. The application as originally filed only generically teaches culturing the cells ‘using any known method’ (See ¶0052-0053 of PGPub). Methods of producing a graft are discussed at ¶0059-0084, but no details about duration of culture nor culture temperature are set forth. The numerical ranges added to the claims find literal support at ¶0072, but are used in the context of applying serum to a substrate to coat the substrate, not in terms of cell culture. There is no support for the new matter in claim 8. As claim 9 depends from claim 8, claim 9 is rejected on the same basis.
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 1-9 and 12-20 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.
Applicants have amended claims 1, 12 and 17 so as to define the preservation solution used as consisting essentially of a HBSS and glucose in a concentration of 1.6 mg/mL.
Per the MPEP at 2111.03, the transitional phrases “comprising”, “consisting essentially of” and “consisting of” define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). Thus, the amendment to claim 1 serves to limit the claimed preservation solution to containing HBSS, 1.6 mg/mL glucose and "those [materials] that do not materially affect the basic and novel characteristics" of the claimed preservation solution; however, the claim is now held to be indefinite because the specification does not clearly define what the "basic and novel characteristics" of the preservation solution are, thus it cannot be readily determined what non-recited elements may be included within the preservation solution and still be within the scope of the claims, and which elements may not.
Furthermore, it is noted that HBSS contains 1000 mg/L of glucose (1 mg/mL; see ThermoFisher Scientific), it is not clear if the total glucose is to be 1.6 mg/mL or, if the claim is requiring 1.6 mg/mL glucose to be combined with HBSS.
All of claims 2-9, 13-16 and 18-20 depend directly or indirectly from claims 1, 12 and 17, and thus are rejected on the same basis.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marksteiner (US 2015/0247856).
Marksteiner discloses skeletal muscle derived cells (SMDC) for use in treatment of a muscle dysfunction (See abstract).
Regarding claim 7: In Example 10 (¶0148) Marksteiner disclose a cell population comprising about 98% CD56+ SMDCs, and thus necessarily 2% non-CD56+ cells. This cell population reads on the cell population of claim 7. For reasons discussed above under Claim Interpretation, the manner by which the cell population was produced is a product-by-process limitation and does not differentiate the final cell population from that of Marksteiner, despite being made by a different process.
Regarding claims 7-9: In Example 18 (¶0162-0164), Marksteiner et al disclose providing four different cell ‘classes’ containing different ratios of CD56+ to CD56- cells. Class 2 comprised 80% CD56+ cells and 20% CD56- cells. Cell class 2 reads on the cell population of claim 7. Marksteiner et al culture each class of cells for 2 days at 37oC (See ¶0164). This culturing step reads on a method for producing a graft comprising culturing the cells of claim 7 on a culture substrate for 1 to 72 hrs. at a temperature between 0 and 60 degrees C. The resulting cell culture after 2 days reads on a graft of claim 9.
Claims 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vilquin et al (US 2004/0043008).
Vilquin et al disclose methods for obtaining cell populations from muscle tissue to use in cell therapies (See abstract).
In Example A, Vilquin et al teach a method for obtaining cell populations from muscle tissue as comprising 6 steps (numbers added by examiner): (1) removal and mincing of a biopsy specimen;
(2) enzymatic dissociation and separation of individual cells by filtration;
(3) culture of the cells and cell expansion phases;
(4) identification of the cell types present at the different stages of cell culture by analysis of specific cell markers;
(5) harvesting of the cells; and
(6) preparation of the cell therapy product (See ¶0099 and 0109-0116).
Vilquin et al elaborate on each step, but for purposes of this rejection, only a few relevant details will be highlighted:
Regarding the step (5) harvesting of the cells: Vilquin et al teach harvesting the cells to obtain a population containing a majority of myoblasts (characterized by CD56+ expression) (See ¶0163, 0172).
The disclosure of Vilquin et al reads on the claims as follows: Regarding claims 7 and 9: Vilquin et al teach their method results in a cell population comprising a majority of CD56+ myoblasts. Table L shows cell populations at various culture passages. In sample MYO003, at passage 2-6, each of the cell populations comprises greater than 80% CD56+ cells, and thus contains less than 20% non-CD56+ cells. These cell populations (at passage 2, 3, 4, 5 and 6) read on the cell population of claim 7. For reasons discussed above under Claim Interpretation, the manner by which the cell population was produced is a product-by-process limitation and does not differentiate the final cell population from that of Vilquin et al, despite being made by a different process. Similarly, the cell culture reads on a graft of claim 9. Again, noting that the manner of production does not differentiate the final product from the cultures of Vilquin et al.
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 ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633