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 7/28/2026 to claims 1-4, 8, 9, and 11-15 have been entered. Claims 5, 16, and 20-23 are canceled. Claim 24 has been added. Claims 1-4, 6-15, 17-19, and 24 remain pending and are being considered on their merits. No claims are withdrawn from consideration. References not included with this Office action can be found in a prior action.
The instant amendments to claim 1 have overcome the 35 U.S.C. § 112(a) and 112(b) rejections of record, which are withdrawn.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 17 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, claims 6 and 17 recite the broad recitation of treating at least one of systemic conditions and diseases; tissue-specific conditions and diseases; for the regeneration of tissues; and for the restoration of function of tissues. However, these claims also depend from claims 1 and 12, respectively, and claim 1 recites “menopause or andropause” and claim 12 recites “andropause”, which are the narrower statement of the limitations towards the diseases to be treated. 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. Correction is required.
Claims 6 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In this case, claim 6 depends from claim 1 and claim 17 depends from claim 12. Claims 6 and 17 fail to further limit the scope of the claims form which they depend because they both recite the broader embodiment of diseases to be treated. Claims 6 and 17 recite the broad recitation of treating at least one of systemic conditions and diseases; tissue-specific conditions and diseases; for the regeneration of tissues; and for the restoration of function of tissues. However, claim 1 recites “menopause or andropause” and claim 12 recites “andropause”, which are the narrower statement of the limitations towards the diseases to be treated.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 and 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-9, 11-15, 18, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by, or, in the alternative, under 35 U.S.C. 103 as obvious over Abuljadayel et al. (US 2011/0091433).
This rejection addresses the embodiment of menopause.
Abuljadayel teaches a method of infusing a (female) menopausal patient, comprising 1) measuring a pre-treatment concentration of circulating reproductive hormones in a menopausal female subject, 2) administering an effective dosage of autologous reprogrammed pluripotent stem cells, pluripotent germ cells, and oocytes, 3) such as to increase the levels of IGF-1, esterdiaol (sic; likely a typo for estradiol) and LDL in the subject as measured by the post-treatment concentration of circulating reproductive hormones in the menopausal female subject (¶0228 and Table 16), anticipating or reading on claims 1-4, 7, 8, 11-15, 18, 19, and 24.
Regarding the functional language of claims 1-4, 6-9, 11-15, 18, and 24 to restore hormone levels to those of a normal (human) subject 18-35 years of age and variations of said language, claim language is not limited by language that does not limit the structure or the manipulative steps of the claim, see M.P.E.P. §2111.04. In the instance case, when the claim is, the functional language has been fully considered and read in light of the specification at ¶0061, ¶0077-0086, and ¶0090-0091 but afforded no patentable weight at this time as such limitations only recite the latent outcome of the claimed methods, absent a showing to the contrary that the combination of reprogrammed pluripotent stem cells, pluripotent germ cells, and oocytes of Abuljadayel cannot meet the functional claim limitations of these claims.
Alternatively regarding the functional language of claims 1-4, 7, 8, 11-15, 18, 19, and 24, the United States and Patent and Trademark Office can require an applicant to prove that the prior art does not necessarily or inherently possess the characteristics of the Applicant’s claims. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). See M.P.E.P. § 2112 in its entirety. In this case, Abuljadayel teaches a substantially identical method comprising administering reprogrammed pluripotent stem cells, pluripotent germ cells, and oocytes to treat menopause in a female subject in need thereof. Therefore and absent any showing to the contrary reasonably commensurate to the scope of the claimed methods, the cells and methods of Abuljadayel inherently meets the functional properties of improvement of the claims. The burden is shifted back to Applicant to overcome the 102 rejection by showing inoperability by a preponderance of evidence, and then to overcome the 103 rejection by showing by a preponderance of evidence that the claimed methods are otherwise nonobvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 6, 10, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Abuljadayel et al. (US 2011/0091433).
The teachings of Abuljadayel are relied upon as set forth above. Abuljadayel further teaches parenteral administration (claim 19), reading on claims 6 and 17.
Regarding claims 6 and 17, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further administer the cells of Abuljadayel parenterally. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Abuljadayel expressly considers the combination, which would be predictably advantageous to deliver the cells of Abuljadayel parenterally to treat symptoms of menopause; see M.P.E.P. § 2143(I)(A).
Regarding the second dosage of claims 10 and 19, dosages and the timing of their administration are results-effective variables which can be optimized. In this case, one of skill in the art would clearly recognize that doses must be timed sufficiently to maintain the efficacy of the drug in vivo and that the timing of dosages can be variable and could easily be optimized by a treating physician based on the needs and physiology of the individual patient. As such, the timing of the dosages would amount to nothing more than routine experimentation that can be optimized on an individual patient basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Abuljadayel et al. (US 2011/0091433).
This rejection addresses the embodiment of andropause.
Abuljadayel teaches a method of infusing a (male) patient suffering from non-obstructive azoospermia, comprising 1) administering an effective dosage of autologous reprogrammed pluripotent stem cells, pluripotent germ cells, and sperm, 2) such as to increase the levels of testosterone in the subject post-administration (¶0230 and Fig. 21), reading in-part on claims 1-4 and 7-9. Abuljadayel envisions treating andropause by administering an effective dosage of pluripotent stem cells, pluripotent germ cell, and/ or sperm (¶0149 and Table 2), reading in-part on claims 1-4 and 7-9. Abuljadayel further teaches parenteral administration (claim 19), reading on claim 6.
Regarding claims 1-4 and 7-9, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the male subjects suffering from non-obstructive azoospermia with male subjects suffering from andropause in Abuljadayel’s cellular treatment methods. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Abuljadayel expressly considers the substitution and which would be predictably advantageous to treat symptoms of andropause in male subjects thereof; see M.P.E.P. § 2143(I)(B).
Regarding the functional language of claims 1-4 and 7-9 to restore hormone levels to those of a normal (human) subject 18-35 years of age and variations of said language, claim language is not limited by language that does not limit the structure or the manipulative steps of the claim, see M.P.E.P. §2111.04. In the instance case, when the claim is, the functional language has been fully considered and read in light of the specification at ¶0061, ¶0077-0086, and ¶0090-0091 but afforded no patentable weight at this time as such limitations only recite the latent outcome of the claimed methods, absent a showing to the contrary that the combination of reprogrammed pluripotent stem cells, pluripotent germ cells, and sperm of Abuljadayel cannot meet the functional claim limitations of these claims.
Alternatively regarding the functional language of claims 1-4 and 7-9, the United States and Patent and Trademark Office can require an applicant to prove that the prior art does not necessarily or inherently possess the characteristics of the Applicant’s claims. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). See M.P.E.P. § 2112 in its entirety. In this case, Abuljadayel envisions a substantially identical method comprising administering reprogrammed pluripotent stem cells, pluripotent germ cells, and sperm to treat andropause in a male subject in need thereof. Therefore and absent any showing to the contrary reasonably commensurate to the scope of the claimed methods, the cells and methods of Abuljadayel inherently meets the functional properties of improvement of the claims. The burden is shifted back to Applicant to overcome the 102 rejection by showing inoperability by a preponderance of evidence, and then to overcome the 103 rejection by showing by a preponderance of evidence that the claimed methods are otherwise nonobvious.
Regarding claim 6, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further administer the cells of Abuljadayel parenterally. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Abuljadayel expressly considers the combination, which would be predictably advantageous to deliver the cells of Abuljadayel parenterally to treat symptoms of non-obstructive azoospermia and/or andropause; see M.P.E.P. § 2143(I)(A).
Regarding the second dosage of claim 10, dosages and the timing of their administration are results-effective variables which can be optimized. In this case, one of skill in the art would clearly recognize that doses must be timed sufficiently to maintain the efficacy of the drug in vivo and that the timing of dosages can be variable and could easily be optimized by a treating physician based on the needs and physiology of the individual patient. As such, the timing of the dosages would amount to nothing more than routine experimentation that can be optimized on an individual patient basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977; and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
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 7-9 of the reply have been fully considered, but not found persuasive of error over the new grounds of rejection necessitated by the instant claim amendments.
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).
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, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Sean C. Barron/Primary Examiner, Art Unit 1653
Prosecution Insights