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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Applicant’s arguments and amendments dated 7/9/26 have been received in the application.
Claims 1, 3, 10-14, 18-20 are currently pending and have been examined on the merits.
Claims 1, 3, 10-12, 19-20 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
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, 3, 10-14, 18-20 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.
Claim 1 contains the limitation “harvesting conditioned medium (CM) from said culture medium in which said ASC were cultured”. It is unclear how a product can be harvested (i.e., extracted) from itself. For examination purposes this limitation is interpreted as comprising “culturing a population of fetal tissue-derived placental adherent stromal cells (ASC) in a culture medium under culturing conditions such that said ASC express CD29, CD49d, and CD54 and do not express CD45 and CD106 [[;]] such that a is produced from said culture medium in which said ASC were cultured; harvesting said conditioned medium wherein ASC-secreted factors are present in said CM”.
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.
Claim(s) 1, 3, 10-14, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Naughton et al., US Patent No. 7,118,746 (cited on IDS dated 4/17/22, hereinafter Naughton) in view of Abramson et al., PCT Publication No. WO 2007/079183 (cited on IDS dated 4/17/22, hereinafter Abramson) and Indumathi et al., (2013) Comparison of fetal-maternal organ derived stem cells in facets of immunophenotype, proliferation, and differentiation. Tissue and Cell, 45: 434-442 (hereinafter Indumathi).
Regarding claims 1, 7-8, 13-14, Naughton discloses conditioned cell culture media and methods of treating various conditions by administering the conditioned media (Abstract). The conditioned media may be conditioned by suitable cell types, including placental cells (col 10 ln 24-38). The cells may be cultured in any manner known in the art, including in monolayer (i.e., adherent), on a 3D substrate, or in a bioreactor (col 10 ln 55-62). In some embodiments, the conditioned media may be used to treat skin conditions such as wrinkling, scarring, skin aging, or other conditions (col 5 ln 54-61, col 28 ln 58-col 29 ln 6, col 29 ln 24-51).
Regarding claims 10-12, the composition may be used in any suitable form, including cream, ointment, or other cosmetics (col 28 ln 51-63, col 33 ln 10-37).
Regarding claims 3, 6, Naughton does not explicitly disclose that the composition is used to treat a side effect of a chemical peel. However, Naughton discloses that the composition may combined with chemical peels to accelerate healing and reduce inflammation (col 29 ln 14-23). Therefore, there is a suggestion present in Naughton that the conditioned media composition could be used to treat side effects of chemical peels.
Regarding claims 10-11, Naughton does not disclose that the composition may be formulated as a cosmetic serum formulation, or foam. However, Naughton discloses that the composition may be “by any known method” (col 28 ln 51-63). It would be obvious to one of ordinary skill in the art to try a cosmetic serum, or foam as known, identified routes of administration for dermal applications with a reasonable expectation that the composition would successfully treat the skin conditions.
Naughton does not disclose that the placental cells demonstrate a certain cell expression profile as per claims 1 and 18-20.
Abrahamson discloses methods of treating skin conditions, including by administering an adherent placental stem cell conditioned culture media (para 6, 33, 207, 228). The conditioned cell culture media produced by the placental stem cells may be used in a therapeutically effective amount to treat various conditions and symptoms thereof, including trauma from cosmetic surgery, and facial dermabrasion (para 207, 217). Abrahamson discloses that placental stem cells are preferably derived from the fetal portion of the placenta (para 56). Following culture under appropriate conditions, the placental stem cells may be sorted for expression of certain markers, such as by flow cytometry (para 34, 143-145, 151 170). The placental stem cells preferably express CD29, CD73, CD90, CD105, and CD200, and do not express CD34, and CD45 (para 8-18, 59-86, 259). The cell population may be sorted such that at least 95% of the placental stem cells are positive for CD200 (para 8-18, 59-86).
As both Naughton and Abrahamson are directed to methods of treating skin conditions using cell conditioned media, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that the placental cells of Abrahamson could be used in the methods of Naughton as simple substitution of one population of placental ASCs for another with a reasonable expectation that the skin conditions could be successfully treated.
The combination does not disclose that the fetal placental stem cells further demonstrate positive expression of CD49d, CD54, and negative expression of CD106.
Indumathi examines the immunophenotype of stem cells derived from the fetal and maternal portions of the placental (Abstract). Indumathi discloses isolating stem cells from both the fetal (amniotic membrane and chorionic plate) and maternal (decidua) portions of the placenta and sorting based on surface antigen expression (2.1-2.3, Table 1). Indumathi discloses that fetal placental cells demonstrate positive expression of CD49d, CD54, CD73, CD90, CD105, and CD166, and do not express CD14, CD31, CD34, CD45, CD106 (3.2, Discussion, Fig. 2-5, Table 2).
As Abrahamson and Indumathi are both directed to the same population of fetal placental derived stem cells, it would be obvious to one of ordinary skill in the art that the fetal placental stem cells of Abrahamson would likewise necessarily demonstrate positive expression of CD49d, CD54, CD73, CD90, CD105, and CD166, and negative expression of CD14, CD31, CD34, CD45, CD106 of Indumathi.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naughton in view of Abramson, and Indumathi as applied to claims 1, 3, 7-8, 10-14, 18-20 above, and further in view of Nixon, A., US Publication No. 2009/0202654 (cited on IDS dated 4/17/22, hereinafter Nixon).
Regarding claims 9, the combination does not disclose that the condition is reduced skin elasticity.
Nixon discloses methods of treating skin conditions by administering an adherent cell conditioned culture media (Abstract, [0011], [0070]). Nixon discloses culturing mesenchymal cells, such as dermal fibroblasts, in monolayer to produce a conditioned media ([0037], [0106]). Nixon discloses that the conditioned media may be used following skin treatments including, chemical peels, laser treatments, micro-needling, and other procedures or events that cause skin trauma ([0027], [0071], [0083]). Nixon discloses that the composition may further be used to treat signs of aging, including wrinkles and loss of elasticity ([0026], [0087], [0164]).
As each of the references are directed to methods of treating skin conditions using cell conditioned media, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that the composition of the combination could be used to treat effects of laser treatment, micro-needling treatment, or loss of skin elasticity as disclosed by Nixon with a reasonable expectation that the skin conditions could be successfully treated.
Response to Arguments
Applicant’s arguments and amendments dated 7/9/26 have been fully considered but are moot in part and not persuasive in part due to the new grounds of rejection necessitated by applicant’s amendments. To the extent that the arguments are pertinent to the current grounds of rejection they are responded to below.
Claim(s) 1-3, 7-8, 10-14, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Naughton in view of Abramson and Indumathi. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naughton in view of Abramson, Indumathi and Nixon.
Applicant argues that Naughton generically mentions placental tissues among many possible tissues, but fails to disclose or suggest the specific population of cells required by the claim (Response p10). Applicant argues that Naughton teaches away from a simple substitution rationale; that Naughton teaches that the cells used materially change the nature of the resultant conditioned media (Response p10-11). Applicant asserts that the teachings of Naughton are limited to the skin-related and tissue-specific cells where skin-related outcomes are desired (Response p11).
In response, a prior art reference is considered good for all that it contains, or suggests, including nonpreferred and broad embodiments. See MPEP § 2123. Naughton explicitly states that placental stem cells may be used to produce conditioned media according to the disclosure. Naughton does not “criticize, discredit, or otherwise discourage the solution claimed”. See MPEP § 2145. Therefore, Naughton is considered relevant prior art for the purposes of a rejection under 35 U.S.C § 103.
Applicant argues that Abrahamson fails to cure the deficiencies noted in Naughton, in particular that the cells express CD29, CD49d, CD54, and do not express CD45 and CD106 (Response p11-12).
As noted above, Abramson explicitly states that the ASCs “express markers CD105, CD33, CD73, CD29, CD44, CD10, AND CD90” and “do not express CD34, CD45, CD117, or CD113” (para 259). Additionally, Indumathi has been cited to demonstrate a more complete expression profile of fetal placenta-derived stem cells. Therefore, the current rounds of rejection obviate the claims as presented.
Applicant argues that the obviousness rejection fails because it does not identify a reason why a one of ordinary skill in the art would have selected the fetal placental stem cells with the particular expression profile claimed without impermissible hindsight (Response p12).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, Naughton discloses that placental stem cell conditioned culture media and methods of treating various skin conditions such as wrinkling, scarring, skin aging, or other conditions. Abramson discloses methods of treating skin conditions, by administering a fetal placental stem cell conditioned culture media wherein the placental stem cells express CD29, CD73, CD90, CD105, and CD200, and do not express CD34, and CD45. Indumathi discloses that fetal placental stem cells necessarily demonstrate positive expression of CD49d, CD54, CD73, CD90, CD105, and CD166, and do not express CD14, CD31, CD34, CD45, CD106. Taken together these references suggest that one of ordinary skill in the art could use a CD49d, CD54, CD73, CD90, CD105, and CD166 positive, CD14, CD31, CD34, CD45, CD106 negative fetal placental stem cell conditioned media to treat skin conditions.
Applicant argues that Nixon fails to cure the deficiencies noted in the combination (Response p14).
In response, the examiner disagrees that the combination fails to obviate the claimed invention for the reasons set forth above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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, Peter Paras can be reached at (571) 272-4517. 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.
/KARA D JOHNSON/Primary Examiner, Art Unit 1632
Prosecution Insights