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 .
Claim Status
In the reply on 01 May 2026 Applicant has amended claim 6; withdrawn claims 1-6, 13-19, and 21. Therefore, claims 1-19 and 21 are pending.
Election/Restrictions
Applicant’s election with traverse of Group II- Claims 7-12 and 20, which are drawn to a method of treatment for wound healing comprising a stem cell conditioned medium in a concentration of 8-10% by volume of the composition, in the reply filed on 01 May 2026 is acknowledged.
Applicants traverse argues that the Examiner's restriction on the ground of a lack of "serious burden" on the Examiner. As set forth in the Manual of Patent Examining Procedure, the criteria for a restriction requirement include: (1) the inventions must be independent or distinct, and (2) there would be a serious burden on the Examiner if the restriction is not required. See M.P.E.P. §§ 802.02 and 803. Specifically, the Applicant stress that: If the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits, even though they include claims to independent or distinct inventions (See remark filed 01 May 2026; p. 9 last two ¶).
This is not found persuasive because Examiner was able to provide art which satisfied the limitations of the product claims without being able to satisfy the limitations of all the method claims thereby demonstrating that a search burden exists between the restricted groups.
Claims 1-6, 13-19, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 7-12 and 20 are under current examination.
Priority
This application was filed 06/19/2023 and is a Continuation in Part of 16486506, filed 08/16/2019, now abandoned and having 1 RCE-type filing therein claims foreign priority to IN201721005531, filed 02/16/2017.
MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 08/16/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/09/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 7-12 and 20 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Also, as per MPEP 2163.03(V), there is a presumption that an adequate written description of the claimed invention is present in the specification as filed.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Possession may be shown in a variety of ways, for example, possession may be shown by describing an actual reduction to practice of the claimed invention. A specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) ("[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim."); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) ("[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves). Alternatively, applicant may present that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
Claims 7 and 20 generally recites method of treatment for wound healing by administering a therapeutic composition, wherein the therapeutic composition comprises a genus of stem cell conditioned medium, which is interpreted as being conditioned medium produced from any type of stem cell. Therefore, the broadest reasonable interpretation of this claim includes any stem cell conditioned medium produced from any type of stem cell.
Instant specification discloses that the adult stem cells may also be obtained from an entire umbilical cord without removal of blood vessels or any other tissue and mixed cell populations maybe obtained comprising mesenchymal stem cells (MSCs), endothelial progenitor cells, fibroblasts and pericytes [SPEC [0027] ¶). Therefore, the specification fails to support the broadest reasonable interpretation of this method claim that includes the therapeutic composition comprising from a genus of any type of stem cell. The broadest reasonable interpretation of this claim includes not only any stem cell but also any stem cell conditioned medium.
The disclosure as originally filed shows a clear reduction to practice of the invention (e.g., as per the Examples and Figures) for specific serum recovered in accordance with Example 1 is used to supplement cell culture medium DMEM/Fl2 at a 5%. The supplemented culture medium is used to culture Embryonic stem cells at a cell density ranging from 1000 to 30000 cells /cm2 in suitable culture vessels. The cells are incubated at 37°C and 5% CO2 till 70-90% confluency is obtained. The stem cell conditioned media is further subject to treatment as per the process of Example 2(a) [0072]. In vivo studies were carried out in an animal model of excisional wound healing where MSC derived conditioned media (CM) was used as treatment group in comparison with normal and sham controls. This study was conducted in compliance with all regulatory and ethical approvals to assess wound healing activity of Human MSC derived conditioned media in laboratory Wistar rat. Healthy young adult Wistar rats were allowed to acclimatize and housed to standard experimental laboratory conditions for a period of 9 days before exposure to the present composition [0074]. Example 2 discloses the culture of stem cell conditioned media from 3 different types of stem cells: Mesenchymal stem cells (as per Example 2a), Embryonic stem cells (Example 2b), and Pluripotent stem cells (Example 2c) [0072]. Example 4 measured wound healing in rats using only conditioned medium from MSCs [0074] and Example 5 describes human hair regeneration studies but does not seem to specify which type of stem cells were used to make the conditioned medium [0076]. Examples 6 and 7 also do not specify which stem cells were used [0077]-[0078].
Therefore, it is apparent that Applicant was in possession of the therapeutic composition comprises a specific stem cell (i.e., Mesenchymal stem cells) for the treatment of wound healing as of the effective filing date.
However, as detailed in MPEP § 2163, besides an actual reduction to practice, Applicant may prove possession of the claimed invention by a showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention. Further, as per MPEP § 2163, “[f]or some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement.”
In the present case, the specification uses specific MSCs for the treatment. However, it is noted, as per the review by Maxson et al. (Stem Cells Transl Med. 2012 Feb 6;1(2):142–149; cited in PTO892) that around the time of the effective filing date, it was well known to utilize Mesenchymal Stem Cells (MSCs), in particular, play an important role in mediating each phase of the wound-healing process inflammatory, proliferative, and remodeling. During the inflammatory phase, MSCs coordinate the effects of inflammatory cells and inhibit the deleterious effects of inflammatory cytokines such as TNF and IFN-γ (Table 1, p. 147 “Conclusion” ¶ of Maxson). Therefore, cited art provides a concise summary of current knowledge of biological properties of MSCs and describes the use of MSCs for wound healing. Therefore, it is obvious that prior art does not support to identify the generic composition comprises any stem cell for wound healing treatment.
Accordingly, it concludes that the claimed wound healing composition comprises any stem cell doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claims 7 and 20 and dependent claims 8-12.
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 of this title, 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.
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 7-12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pineiro et al. (EP2770050; cited in IDS filed 09/09/2025; hereinafter “Pineiro”) in view of Mathen (IN1471/MUM/2014; cited in IDS filed 09/09/2025; hereinafter “Mathen”), and Nixon (WO2007070850; cited in IDS filed 09/09/2025; hereinafter “Nixon”), further in view of Stack (US20020037268; cited in PTO892; hereinafter “Stack”).
Regarding claims 7, 20 Pineiro teaches a method for isolating stem cells comprising preparing a cell suspension from uterine cervix tissue and to the conditioned medium obtained from the culture of said stem cells for treating or preventing cancer, inflammatory diseases, autoimmune diseases, chronic pathologies or infectious diseases (i.e., ulcer [0063]), as well as for cosmetic treatment (abstract). The cells are cultured without differentiation on a solid surface, in the presence of a suitable cell culture medium [e.g. DMEM, DMEM-F12, alpha-MEM, RPMI, typically supplemented with 5-25% (e.g. 20%) of a suitable serum ([0020] of Pineiro).
The conditioned medium contains metabolites, growth factors, and extracellular matrix proteins secreted into the medium by the cultured cells. Examples of each component include, but not limiting to, metabolites such as glucose, amino acids, nucleosides, etc.; growth factors, such as interleukins, EGF (epidermal growth factor), PDGF (platelet-derived growth factor), etc.; and matrix proteins such as collagen, fibronectin, various proteoglycans, etc. Once the cell of the invention is isolated, both the cell and the conditioned medium obtained from it can be used for manufacture a pharmaceutical composition ([0047], [0079], claims 12-15 of Pineiro).
Therefore, Pineiro teaches that the pharmaceutical composition comprising an isolated stem cell, a cell population, or the conditioned medium of the invention, hereinafter "pharmaceutical composition of the invention", and an acceptable pharmaceutically carrier and/or an adjuvant ([0043-0049] of Pineiro), wherein the cell, the cell population, the conditioned medium or the pharmaceutical composition of the invention for use in a cosmetic treatment.
Still Pineiro does not expressly teach serum extracted from fresh frozen plasma (FFP). However, such was known in the prior art.
With respect to claim 7, and 20 Mathen teaches a method of separation of human serum from human fresh frozen plasma (FFP). The reference also discloses a method of culturing and cryopreserving clinical grade Human Mesenchymal Stem Cells using human serum recovered from human fresh frozen plasma (FFP), under xeno-free conditions, useful for therapeutic purposes (p. 4-5th ¶- p. 6 1st ¶ of Mathen). Mathen further teaches the cell culture medium selected from Dulbecco's modified essential medium (DMEM) supplemented with 5–30% human serum recovered from human fresh frozen plasma (FFP) (p. 3rd ¶ of Mathen).
Regarding claim 20, Mathen further teaches that the stem cell conditioned medium is obtained by cultivating stem cells in a culture medium supplemented with 5 to 30% serum extracted from fresh frozen plasma (FFP), the process for extracting serum comprising: a) preparing the growth supplement of human serum by pooling fresh frozen plasma (FFP) from between single to multiple lots to reduce lot to lot variability of the biological component; b) treating FFP or CDP with 2%-20% calcium chloride to separate human serum and to remove clotting factors and cryoprecipitate in plasma; followed by allowing the clotting process to proceed at room temperature for 2-8 hours and then at 4-8°C overnight to obtain serum from the clot; c) separating calcium chloride treated FFP or CDP of step (b) under sterile conditions followed by inactivating the complement system by maintaining serum in a water bath at 56°C for 30 mins followed by cooling; d) adding 0.01% - 5% peracetic acid (PAA) to serum obtained in step (c) to oxidize and inactivate viruses or bacteria present and keeping the same for 30 minutes to 1 hour; e) adding sterile sodium bisulphite at a concentration of between 100-200 mg/100 ml to step (d), to neutralize the effect of PAA; f) filtering the serum of step (e) first through 0.8μm followed by filtration through 0.2μm filter, and aliquoting in sterile containers followed by storing at -20°C (See p. 7 1st and 3rd ¶ of Mathen)
Still Pineiro does not expressly teach cytokines and growth factors. However, such was known in the prior art.
With respect to claims 7, 9-12, and 20 Nixon teaches a pharmaceutical skin care composition preparation, the product containing a conditioned cell medium is topically applied to treat skin conditions, such as promoting wound healing [0011-0013]. The composition can include any appropriate pharmaceutically acceptable carrier [0012], compositions preferably hypoallergenic and pH controlled and include components are oils, fats, surfactants, humectants (i.e., Glycerin), thickening agents (i.e., xanthan), antioxidants, viscosity stabilizers (i.e., propylene glycol), buffers, preservatives, perfumes, and further ingredients may be incorporated in the compositions, e.g. anti-inflammatory agents, antibacterials, anti-fungal (sodium or potassium salt), disinfectants, vitamins, healing enhancers/fibroblast proliferation compounds [0088]-[0089]. Nixon teaches that the composition further include growth agents synthesized from cultured cells from skin (abstract) such as basic fibroblast growth factor (bFGF) which is human fibroblast [0037]; granulatory colony stimulating factor (GCSF); insulin-like growth factor (IGF); vascular endothelial growth factor (VEGF), interleukin-6, HGF; L-1RA ([0034]-[0035]).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Pineiro et al., as suggested by Mathen and Nixon and produce the instant invention. One of ordinary skill in the art would have been motivated to have serum from FFP because FFP is a suitable material to make serum as suggested by Mathen (p. 4 last ¶ of Mathen) that accelerated and aesthetic wound healing (p. 10 3rd ¶ of Mathen). MPEP 2144.07. Therefore, it is obvious for one of ordinary skill in the art to have serum from FFP and produce instant claimed invention with reasonable expectation of success.
Regarding claim 7, prior arts teach the cosmetic composition comprising an excipient and stem cell condition medium obtained by cultivating stem cells in a culture medium supplemented with 5-25% (e.g. 20%) of a suitable serum from FFP. Since the range of a stem cell condition medium is so broad from 0.5% to 100%, it is obvious to have such claimed range in the cosmetic composition with reasonable expectation of success. MPEP 2144.05 (II) states the Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Regarding claim 7, since Nixon teaches each of cited growth factors in claim 7 in the course of culture, and prior arts teaches the same or substantially same culture process and stem cell condition medium, the same culture process and stem cell condition medium are expected to have the same growth factors in the claimed range with reasonable expectation of success. See MPEP 2144.05 (II). Nixon further teaches that pharmaceutical compositions are desirable in unitary dosage form suitable, particularly, for topical or percutaneous administration [0073-0074]. Accordingly, it would have been obvious to POSITA to use sufficient pharmaceutical compositions with pharmaceutically acceptable excipients taught by Nixon to treat wounds in order to obtain desired therapeutic outcome of the method with a reasonable expectation of success. One skilled in the art would recognize that the dosage of pharmaceutical compositions for the desired outcome in treating the wounds without introduce to having significant deleterious effect on the skin would be routine optimization of administrating composition on wounds/ day. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144(II)(A).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Still Pineiro does not expressly teach an anti-oxidant selected from EDTA. However, such was known in the prior art.
Regarding claim 20, Stack teaches an antimicrobial sanitizing lotion produced by a method comprising the steps of: 1) forming a surfactant phase mixture, based upon a percentage by weight of the total composition, by first combining 83.5 wt.% deionized water, 0.16 wt. % EDTA Sodium Salt and 0.35 wt.% of an acrylic polymer (claim 1, 17 of Stack).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Pineiro as suggested by Stack, and produce the instant invention. One of ordinary skill in the art would have been motivated to include EDTA from 0.05% to 2% because EDTA is a suitable ingredient in lotion, MPEP 2144.07. Under guidance from Stack teaches lotion comprising EDTA at 0.1 6%, it is obvious for one of ordinary skill in the art to include EDTA from 0.05% to 2% and produce instant claimed invention with reasonable expectation of success. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claim 8, Pineiro teaches that the term "cosmetic treatment" refers to the treatment to ameliorate the appearance of the skin, e. g. by improving the skin texture, in particular for the application to aged skin, in particular to crinkled, wrinkled and/or dimpled (cellulite) skin. In this case, the cosmetic preparation is preferably formulated as cream, lotion, gel or wax, and may comprise a compound for improving the cosmetic effect ([0068-0069] of Pineiro).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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