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 12/11/25 have been received in the application.
Claims 1-3, 7-14, 18-20 are currently pending and have been examined on the merits.
Claims 19-20 are newly added.
Claims 1-3, 7-12, 18 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Withdrawn Objections & Rejections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 Any objections rejections not specifically reiterated are hereby withdrawn.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 Objections
Applicant is advised that should claim 1 be found allowable, claims 19-20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 19-20 are directed to optional limitations and do not add any further requirements to the claim from which they depend.
Claim Rejections - 35 USC § 112
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 19-20 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. Claims 19-20 are directed to optional limitations and do not add any further requirements to the claim from which they depend. 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 § 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, 7-8, 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).
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 2-3, 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). 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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naughton in view of Abramson 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 12/11/15 have been fully considered but are not as explained in detail 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. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naughton in view of Abramson and Nixon.
Applicant argues that neither Naughton not Abramson disclose a cultured placental ASC population which expresses CD29 and does not express CD45 (Response p8-9).
In response, 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). Therefore, applicant’s arguments are considered spurious.
Applicant also argues that Naughton discloses teaches a multi-cell type CM containing factors from at least two distinct cell types, which differs from the single placental ASC-derived CM of the present invention (Response p9).
The present claims utilize the open transitional phrase “comprising” which is inclusive or open-ended and does not exclude additional unrecited elements or method steps. As long as the recited method steps are present in the prior art, any additional elements present are immaterial. Further, eve if applicants had precluded the use of additional elements, the sections to which applicants point in support of their position are recited as alternative embodiments of the disclosed invention (e.g., “may further be cultured”, “may also be inoculated”). Naughton explicitly states that in some embodiments the CM may be produced “with or without additional cells” (col 4 ln 55-col 5 ln 22, col 11 ln 5-10, col 13 ln 17-34). Therefore, Naughton explicitly discloses embodiments, in which a single cell type may be used to produce the CM.
Applicant argues that treatments intended for augmentation and regeneration require work to be performed by cells contained in the CM, whereas ameliorating or repairing requires the work to be performed by factors contained within the CM (Response p10).
It is unclear what applicant is intending to convey with this argument. Naughton explicitly states that the “conditioned medium may be formulated for eliminating wrinkles” (col 29 ln 24-26). Naughton clearly discloses that the CM itself is utilized for treating the skin condition.
Applicant argues that Abrahamson fails to cure the deficiencies noted in Naughton, in particular that the cells are CD29+ and CD45- (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).
Applicant further argues that Abramson only discloses treating conditions such as facial dermabrasion or burn and wound repair in the context of regeneration or replacement therapies (Response p11). Applicant argues that the invention does not rely on tissue regeneration by only on bioactive components in the culture medium (Response p11-12).
Applicant appears to arguing that the modes of action between the present invention and the prior art differ. As currently presented, the claims do not require that the treatment have a certain mode of action, merely that the skin condition is ameliorated or treated. The cited prior art demonstrates that administration of the CM results in treatment of skin conditions (See e.g., Naughton col 3 ln37-48 “the secretion of extracellular proteins into conditioned cell media such as growth factors, cytokines, and stress proteins opens new possibilities in the preparation of products for use in a large variety of areas including tissue repair, e.g., in the treatment of wounds and other tissue defects such as cosmetic defects”, col 29 ln 24-51 “[t]he conditioned medium may be formulated for eliminating wrinkles, frown lines, scarring and other skin conditions instead of using silicone or other products to do so. The conditioned medium contains growth factors and inflammatory mediators such as, for example, VEGF, HGF, IL-6, IL-8, G-CSF and TFG B (See Table 3, in Section 5.8.1) as well as extracellular matrix proteins such as type I and type III collagens, fibronectin, tenascin, glycosaminologycans, acid and basic FGF, TGF-C. and TGF-B, KGF, versican, decorin betaglycens, syndean and various other secreted human dermal matrix proteins which are useful in repairing physical anomalies and cosmetic defects”). Therefore, applicants arguments are not considered persuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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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.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632