DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 2/26/2026 to claim 1 have been entered. Claims 2, 20, and 21 are canceled. Claims 1 and 3-19 remain pending, and being considered on their merits. References not included with this Office action can be found in a prior action.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 11-19 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation a generic subject, and the claim also recites “for a 70 kg human” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In so much that claims 12-19 depend from claim 11 and do not resolve the point of confusion, these claims must be rejected with claim 11 as indefinite.
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, 3-9, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ichim et al. (US 2012/0269774) in view of Sinden et al. (US 2015/0079046).
In view of the indefiniteness rejections above and in the interest of compact prosecution, this rejection addresses the embodiment of human subjects for claim 11.
This rejection addresses the embodiment of not co-administering stem cells for claims 1 and 11. See M.P.E.P. § 2111 for the broadest reasonable interpretation standard applied during prosecution; in this case, claims 1 and 11 that recite “without administering stem cells” does not distinguish between co-administration of exosomes with stem cells and prior administration of stem cells.
Ichim teaches methods of administering mesenchymal stem cells to subjects to treat a disease in said subjects (claim 2 and Example 3 for bone marrow stem cells; also [0039]), reading in-part on claim 1, 6, 11, and 15. In a separate embodiment, Ichim teaches administering mesenchymal stem cells to subjects to treat a stroke (Example 4), reading in-part on claim 11. Ichim teaches administering exosomes obtained from mesenchymal stem cells to recipients of stem cells to allow for immunological tolerance ([0095]), reading on claims 1, the negative limitation of claims 1 and 11 (e.g. the embodiment of exosomes administered either before or after a treatment with stem cells), claims 3, 4, and 11-13. Ichim teaches treating schizophrenia as a species of neurological diseased to be treated (claim 6 and [0032]), reading in-part on claim 1. Ichim teaches a pharmaceutical composition prepared from 104-108 cord blood cells/ml ([0118]), reading on claims 1 and 11. Ichim teaches that cord blood comprises CD34+ hematopoietic stem cells and mesenchymal stem cells ([0119]-[0120]), reading on the MSC-derived exosomes of claims 1, 3-5, and 11-13. Ichim teaches obtaining human mesenchymal stem cells from dental pulp ([0131), reading on claims 5, 8, 14, and 17. Ichim teaches adipose derives stem cells ([0045]), reading on claims 7 and 16. Ichim teaches allogeneic stem cells ([0027]), reading on claims 9 and 18. Ichim teaches administering a dose of 5 x 107 nucleated cord blood cells per kg to human subjects and which comprises stem cells (Example 5, particularly [0166]), reading in-part on the particle dosage of claim 11.
Regarding claims 1 and 11, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See M.P.E.P. § 2111.02 and 2111.04 In this case, “as an active ingredient effective for treating…” has been fully considered but is a statement of intended outcome of the claimed methods. Therefore and in the absence of any showing to the contrary, the exosome composition of Ichim is reasonably construed as being inherently capable of meeting these limitations of claims 1 and 11.
Regarding claim 1, Ichim does not teaching a single embodiment of a method comprising administering an effective amount of exosomes obtained from mesenchymal stem cells to treat at least one symptom of schizophrenia in subjects. Regarding claims 1 and 11, Ichim does not teach intranasal administration. Regarding claim 11, Ichim does not teach administering 109-1015 for a 70 kg human (and equating to about 1.4 x 105 to 1.4 x 1013 particles per kg) as an effective amount of exosomes obtained from mesenchymal stem cells to treat at least one symptom of stroke in subjects.
Sinden teaches methods of obtaining microparticles, exosomes, membrane particles, ectosomes, or exovesicles from neural stem cells ([0008]-[0010]), reading in-part on claims 1 and 11 and alternatively on those embodiments of claims 3 and 12. Sinden envisions treating schizophrenia in subjects by administration of therapeutically effective dosages of the microparticles/exosomes and which would be apparent to a person skilled in the art ([0011], [0017], [0171], and [0195], and [0199]), reading in-part on claims 1 and 11. Sinden envisions treating stroke in subjects by administration of therapeutically effective dosages of the microparticles/exosomes and which would be apparent to a person skilled in the art ([0011], [0011], [0171], [0176], and [0195]), reading in-part on claim 11. Sinden teaches that the microparticle composition can be administered by any appropriate route, which would be apparent to the skilled person depending on the disease or condition to be treated and that a typical route of administration includes intranasal administration ([0170]), reading on claims 1 and 11.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat subjects suffering from schizophrenia as envisioned by Ichim with the composition comprising mesenchymal stem cell exosomes of Ichim in view of Sinden. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Sinden and Ichim and directed in-part towards treating psychiatric disorders with a composition comprising exosomes obtained from stem cells, and because Sinden that a therapeutically effective dosage would be apparent to a person skilled in this art. The skilled artisan would have been motivated to do so because while Ichim teaches a relatively long list of disorders to be treated, Sinden teaches a much shorter list of psychiatric disorders and both Ichim and Sinden are directed in-part towards treating schizophrenia and so Sinden would thus point a person of ordinary skill in the art to the embodiment of treating schizophrenia of Ichim and so would predictably yield a method of treating subjects suffering from schizophrenia. The skilled artisan also would have been motivated to do so because Ichim’s mesenchymal stem cell exosomes composition would be predictably advantageous to allow for immune tolerance when treating subjects suffering from schizophrenia as envisioned by Ichim.
Regarding claims 1 and 11, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further administer the mesenchymal stem cell exosomes of Ichim intranasally in view of Sinden. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Sinden and Ichim and directed in-part towards treating psychiatric disorders with a composition comprising exosomes obtained from stem cells. The skilled artisan would have been motivated to do so because Sinden teaches that the stem cell microparticle composition can be administered by any appropriate route, which would be apparent to the skilled person depending on the disease or condition to be treated and that a typical route of administration includes intranasal administration, and so the addition would predictably yield an operable route of administration for treating schizophrenia as envisioned by Ichim with Ichim’s mesenchymal stem cell exosome composition.
Regarding claim 11, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat subjects suffering from stroke as envisioned by Ichim with the composition comprising mesenchymal stem cell exosomes of Ichim in view of Sinden. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Sinden and Ichim and directed in-part towards treating stroke with a composition comprising exosomes obtained from stem cells, and because Sinden that a therapeutically effective dosage would be apparent to a person skilled in this art. The skilled artisan also would have been motivated to do so because Ichim’s mesenchymal stem cell exosomes composition would be predictably advantageous to allow for immune tolerance when treating subjects suffering from stroke as envisioned by Ichim.
Regarding the particle dosages of claim 11, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Ichim teaches a stem cell dosage within the claimed range and so would be reasonably informative to a person of ordinary skill in the art as a starting point for optimization of the claimed dosage of exosomes obtained from mesenchymal stem cells, and because Sinden as a whole teaches that optimization of microparticle/exosome dosages are well within the skill of a person of ordinary skill in the art. Thus, the burden is shifted back to establish criticality of the claimed dosage range by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ichim and Sinden as applied to claim 1 and 11 above, and further in view of Gho et al. (US 2012/0177574).
The teachings of Ichim and Sinden are relied upon as set forth above.
Regarding claims 10 and 19, Ichim and Sinden do not teach non-allogeneic mesenchymal stem cell particles. This rejection addresses the embodiment of autologous mesenchymal stem cell particles.
Gho teaches methods of obtaining microvesicles from nucleated mammalian cells (Abstract). Gho teaches obtaining the microvesicles from mesenchymal stem cells ([0154]). Gho teaches that for autologous microvesicles for when the microvesicles are to be administering to a subject to preclude induction of immune responses ([0153]), reading on claim 10 and 19.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the allogeneic source(s) of mesenchymal stem cells exosomes of Ichim with the autologous source(s) of mesenchymal stem cell microvesicle particles of Gho in Ichim’s methods A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Ichim and Gho are directed towards obtaining similar compositions, i.e. exosomes and microvesicles respectively, from mesenchymal stem cells. The skilled artisan would have been motivated to do so because Gho teaches that autologous source are advantageous to preclude induction of immune responses when the mesenchymal stem cell particles are to be administered to subjects.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 11-13, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Xin et al. (Journal of Cerebral Blood Flow & Metabolism (2013) 33, 1711–1715) in view of Sinden et al. (US 2015/0079046).
In view of the indefiniteness rejections above and in the interest of compact prosecution, this rejection addresses the embodiment of murine subjects for claim 11.
Xin teaches a method of treating stroke in rat subjects thereof, the method comprising administering a therapeutically effective dosage of exosomes obtained from allogeneic rat bone marrow mesenchymal stem cells (“Materials and Methods” on p1711-1712) such as to improve neurologic outcome vs. control-treated subjects. (Fig. 2), reading in-part on claims 11-13, 15, and 18. Xin teaches administering a dosage of 100 µg of MSC-derived exosomes to the subjects and which is effective to treat symptoms of stroke in the rat subjects (the paragraph spanning p1711-1712 and Figure 2), reading in-part on the particle dosage range of claim 11.
Regarding the particle dosages of claim 11, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Xin teaches that administering a dosage of 100 µg of MSC-derived exosomes to the subjects is effective to treat symptoms of stroke in the rat subjects. Thus, the burden is shifted back to establish criticality of the claimed dosage range by objective evidence.
Regarding claim 11, Xin does not teach intranasal administration.
Sinden teaches methods of obtaining microparticles, exosomes, membrane particles, ectosomes, or exovesicles from neural stem cells ([0008]-[0010]), reading in-part on claim 11 and alternatively on those embodiments of claim 12. Sinden envisions treating stroke in subjects by administration of therapeutically effective dosages of the microparticles/exosomes and which would be apparent to a person skilled in the art ([0011], [0011], [0171], [0176], and [0195]), reading in-part on claim 11. Sinden teaches that the microparticle composition can be administered by any appropriate route, which would be apparent to the skilled person depending on the disease or condition to be treated and that a typical route of administration includes intranasal administration ([0170]), reading on claim 11.
Regarding claim 11, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further administer the mesenchymal stem cell exosomes of Xin intranasally in view of Sinden. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Sinden and Xin and directed in-part towards treating psychiatric disorders with a composition comprising exosomes obtained from stem cells. The skilled artisan would have been motivated to do so because Sinden teaches that the stem cell microparticle composition can be administered by any appropriate route, which would be apparent to the skilled person depending on the disease or condition to be treated and that a typical route of administration includes intranasal administration, and so the addition would predictably yield an operable route of administration for treating schizophrenia as envisioned by Xin with Xin’s mesenchymal stem cell exosome composition.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 14, 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Xin and Sinden as applied to claim 11 above, and further in view of Ichim et al. (US 2012/0269774).
The teachings of Xin and Sinden are relied upon as set forth above.
Regarding claim 14, Xin and Sinden do not teach wherein the mesenchymal stem cells are derived from dental pulp. Regarding claim 16, Xin and Sinden do not teach wherein the mesenchymal stem cells are derived from adipose tissue. Regarding claim 17, Xin and Sinden do not teach wherein the MSCs (i.e. mesenchymal stem cells) are human.
Ichim teaches methods of administering mesenchymal stem cells to subjects to treat a disease in said subjects (claim 2 and Example 3 for bone marrow stem cells; also [0039]). In a separate embodiment, Ichim teaches administering mesenchymal stem cells to subjects to treat a stroke (Example 4). Ichim teaches administering exosomes obtained from mesenchymal stem cells to recipients of stem cells to allow for immunological tolerance ([0095]). Ichim teaches obtaining human mesenchymal stem cells from dental pulp ([0131), reading on claims 14, 17, and the embodiment of human cells for the non-allogeneic cells of claim 19. Ichim teaches adipose derives stem cells ([0045]), reading on claim 16.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the bone marrow MSC source of Xin with the dental pulp MSCs of Ichim source for claim 14, the bone marrow MSC source of Xin with the adipose tissue MSCs of Ichim source for claim 16, rat MSC source of Xin with the human MSCs of Ichim source for claims 17 and 19, because the different sources of MSCs are all explicitly taught as being useful for THE SAME PURPOSE as sources of MSCs to produce exosomes. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 11-13 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 of copending Application No. 17/959,327 (reference application) in view of Xin et al. (Journal of Cerebral Blood Flow & Metabolism (2013) 33, 1711–1715).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 10 of the ‘327 Application is directed towards a method of treating subjects for a condition other than epilepsy by administering a composition comprising a mesenchymal stem cell-derived exosome, reading in-part on claims 11-13. Claim 11 of the ‘327 Application recites treatment of stroke, reading in-part on claim 11. Claim 12 of the ‘327 Application recites intranasal administration, reading in-part on claim 11.
While the ‘327 Application does not recite every element of instant claim 11 in a single claim, instant claims 11-13 must be held prima facie obvious over claims 10-12 of the ‘327 Application because combining separate steps taught as useful in a method into a singular method must be held as prima facie obvious, as each step is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding claim 11, the ‘327 Application does not teach a particle dosage in the range of 109-1015 for a 70 kg human.
Xin teaches a method of treating stroke in rat subjects thereof, the method comprising administering a therapeutically effective dosage of exosomes obtained from allogeneic rat bone marrow mesenchymal stem cells (“Materials and Methods” on p1711-1712) such as to improve neurologic outcome vs. control-treated subjects. (Fig. 2), reading in-part on claim 11 and 18. Xin teaches administering a dosage of 100 µg of MSC-derived exosomes to the subjects and which is effective to treat symptoms of stroke in the rat subjects (the paragraph spanning p1711-1712 and Figure 2), reading in-part on the particle dosage range of claim 11.
Regarding the particle dosages of claim 11, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, Xin teaches that administering a dosage of 100 µg of MSC-derived exosomes to the subjects is effective to treat symptoms of stroke in the rat subjects. Thus, the burden is shifted back to establish criticality of the claimed dosage range by objective evidence.
Regarding claim 18, t would have been obvious to a person of ordinary skill in the art before the invention was filed to utilize an allogeneic source of MSCs in the methods of the ‘327 Application in view of Xin A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both the ’327 Application and Xin are directed towards methods of treating stroke in subjects by administering mesenchymal stem cell-derived exosomes. The skilled artisan would have been motivated to do so because the ‘327 Application is generic with respect to the source of the mesenchymal stem cells, and so Xin’s allogeneic and exemplary source of mesenchymal stem cells would be a predictable source of mesenchymal stem cells in the methods of the ‘327 Application.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 14, 16, 17, and 19 are rejected for nonstatutory double patenting as being unpatentable over claims 10-12 of copending Application No. 17/959,327 and Xin as applied to claim 11 above, and further in view of Ichim et al. (US 2012/0269774).
The teachings of the ‘327 Application and Xin are relied upon as set forth above.
Regarding claim 14, the ‘327 Application and Xin do not teach wherein the mesenchymal stem cells are derived from dental pulp. Regarding claim 16, the ‘327 Application and Xin do not teach wherein the mesenchymal stem cells are derived from adipose tissue. Regarding claim 17, the ‘327 Application and Xin do not teach wherein the MSCs (i.e. mesenchymal stem cells) are human.
Ichim teaches methods of administering mesenchymal stem cells to subjects to treat a disease in said subjects (claim 2 and Example 3 for bone marrow stem cells; also [0039]). In a separate embodiment, Ichim teaches administering mesenchymal stem cells to subjects to treat a stroke (Example 4). Ichim teaches administering exosomes obtained from mesenchymal stem cells to recipients of stem cells to allow for immunological tolerance ([0095]). Ichim teaches obtaining human mesenchymal stem cells from dental pulp ([0131), reading on claims 14, 17, and the embodiment of human cells for the non-allogeneic cells of claim 19. Ichim teaches adipose derives stem cells ([0045]), reading on claim 16.
A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the generic MSC sources of the ‘327 Application with the human dental pulp MSCs of Ichim for the source of claim 14, with the adipose tissue MSCs of Ichim for the source of claim 16, and with the human MSCs of Ichim for the source of claims 17 and 19, because the different sources of MSCs are all explicitly taught as being useful for THE SAME PURPOSE as sources of MSCs to produce exosomes. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 5-12 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine Sinden and/or Gho with Ichim on pages 7-8 of the reply, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Applicant’s arguments are not found persuasive because they are predicated on an overly narrower interpretation of the scope of claims 1 and 11 that cannot be held as the broadest reasonable interpretation. See M.P.E.P. § 2111 as a whole. Claims 1 and 11 recite “without administering stem cells” as a negative limitation and the open-ended “comprising” transitional phrase, and so the broadest reasonable interpretation of the scope of these claims only excludes stem cell administration from the single intranasal administration step and does not exclude either prior and future administration of stem cells as alleged.
In response to applicant's arguments against the references individually on pages 8-9 of the reply, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, none of Applicant’s arguments address the specific rationale of record to combine Sinden with Ichim, that the skilled artisan also would have been motivated to do so because Ichim’s mesenchymal stem cell exosomes composition would be predictably advantageous to allow for immune tolerance when treating subjects suffering from schizophrenia as envisioned by Ichim.
If Applicant is alleging it would be unpredictable to combine Sinden with Ichim, than the arguments are not persuasive because absolute predictability is not a prerequisite for a prima facie case for obviousness (see M.P.E.P. § 2143.02 (I)), and because Applicant has not asserted any technical reasoning supported by the evidence of record that it would otherwise be unpredictable to combine Sinden with Ichim.
On page 9 of the reply, Applicant alleges that combining Sinden with Ichim would alter the principle of operation of Ichim. This is not found persuasive because Ichim is clearly and unambiguously directed towards methods of treating schizophrenia in subjects by administering stem cells and by further administering exosomes, and so the fact that the inventor (may have) recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
On page 9 of the reply, Applicant alleges that the combination of Sinden’s intranasal administration route with Ichim’s methods would render Ichim inoperable. This is not found persuasive because Applicant’s arguments are hypothetical and not supported by evidence in the record at this time; inoperability of the prior art requires objective evidence submitted as an Affidavit or Declaration, see M.P.E.P. § 716.01(c).
On pages 9-10 of the reply, Applicants rely on arguments traversing the above rejection of claims 1 and 11 over Ichim in view of Sinden to traverse the rejection of claims 10 and 19 further in view of Gho. Therefore, the response set forth above to arguments also applies to this rejection.
On pages 10-11 of the reply, Applicant alleges the instant claim amendments to claim 11 have overcome the obviousness rejections of record over Xin in view of Sinden. This is not found persuasive over the modified grounds of rejection above. Briefly restated, the broadest reasonable interpretation of claim 11 is still permissive of the rat subjects of Xin, and new grounds of rejection have been added to address the particle dosage range added to the claim.
Conclusion
No claims are allowed. No claims are free of the art.
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 SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653