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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/14/2025 is acknowledged. A Notice of Improper Request for Continued Examination and a Notice of Non-Compliant Amendment alleging that the amendment is unsigned or not signed in accordance with 37 CFR 1.4 was mailed by a Legal Instruments Examiner on 8/19/2025. Applicant submitted claim amendments and remarks on 8/19/2025. A Notice of Non-Compliant Amendment was mailed 9/30/2025 because the claim amendment received 8/19/2025 (as well as the claim amendment received 8/14/2025) listed claims 18-20 as new and did not list claims 21-24, which is non-compliant because claims 18-24 were entered with the claim amendment received 9/5/2024 and withdrawn as drawn to a non-elected invention because claims 18-24 were drawn to an invention independent or distinct from the invention elected on 9/18/2023 and examined in the Office actions mailed 10/18/2023 (non-final) and 4/4/2025 (final). A compliant claim amendment was received 10/20/2025 and Power of Attorney was received 4/23/2026 and accepted 4/28/2026.
Status of Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 10/20/2025 are acknowledged. Claims 8 and 17 are amended; claims 13-16 are canceled; claims 25-27 are new; claims 1-12 and 17-27 are pending; claims 1-7, 18-24 and 26 are withdrawn (see below); claims 8-12, 17, 25 and 27 have been examined on the merits.
Election/Restrictions
New claim 26 is drawn to an invention that is independent or distinct from the invention elected on 9/18/2023 and confirmed in the response received 4/12/2024 (p. 1).
Applicant has received an action on the merits for the elected invention mailed 10/18/2023. Accordingly, claim 26 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim 26 constitutes a patentably distinct invention from the elected invention of Group II, claims 8-17 (now claims 8-12, 17, 25 and 27), drawn to a process of culturing UC MSCs and producing conditioned medium, as follows:
Inventions II (elected invention of claims 8-12, 17, 25 and 27 drawn to a process of culturing umbilical cord mesenchymal stem cells, UC MSCs, and producing conditioned medium) and invention I (original claims 1-7 and new claim 26 drawn to a factor rich composition which is a conditioned medium) are related as process of making (II) and product made (I). The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the process of Invention II can be used to make a materially different product – a composition of collagen (see specification - [0018], [0053], [0066], [0078] and Fig. 9). Additionally, the composition of Invention I can be produced by a materially different process, such as culturing UC MSCs, collecting the conditioned medium and filtering the conditioned medium. Hence, the inventions are independent or distinct. Because of their distinction between each other and because the search requirements of invention II are not the same as the search requirements for invention I, restriction for examination purposes is deemed proper. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Thus, claims 1-7, 18-24 and 26 are withdrawn and claims 8-12, 17, 25 and 27 have been examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121 or 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The instant application is a continuation-in-part of 17205910, which is a divisional application of 15248629 and claims priority to provisional application 62213537.
The disclosures of the prior-filed applications, Application Nos. 17205910, 15248629 and 62213537, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed applications do not disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm; as 17205910, 15248629 and 62213537 only disclose sterile filtering the conditioned media through a 0.22 µm filter and do not mention 0.45 µm filters nor any combination filtering through multiple filters; therefore, the effective filing date of claims 8-12 and 17 is the filing date of the instant application, 7/30/2021.
Response to Arguments
Applicant's arguments filed 8/19/2025, duplicative of the arguments filed 8/14/2025, have been fully considered but they are not persuasive. Regarding the priority determination (that the effective filing date of claims 8-12, 17, 25 and 27 is the filing date of the instant application, 7/30/2021), Applicant argues (pp. 1-2) that there is “Explicit Support in Parent Specification” by providing support from the instant specification (p. 1, ¶3-7). Passages from the instant specification show that the instant specification (filed 7/30/2021) provides support for the claims but does not demonstrate support from the parent application, i.e., 17205910.
Regarding applications 17205910, 15248629 and 62213537, Applicant argues (pp. 1-2) “any subject matter disclosed therein-either explicitly or inherently-forms part of the written description support for the pending claims” (p. 2, ¶1). This is correct, but applications 17205910, 15248629 and 62213537 DO NOT explicitly or inherently disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm.
Applicant alleges that “Even if the specific filtration sequence was not described verbatim in the earlier applications, the techniques of filtering conditioned medium to remove aggregates and sterilize were thoroughly described as part of the process of preparing the UC MSC-derived product”. This is incorrect. Applications 17205910, 15248629 and 62213537 do not describe removing aggregates, do not describe filtration of the conditioned medium other than filter sterilization with a single 0.22 µm filter and/or concentration of the conditioned media with Centricon devices.
Specifically, 62213537 recites “Thaw all the conditioned media collected overnight at 4C. Combine conditioned media before performing the cytokine study analysis. Filter the pooled media with 0.22 microns filter. Sample Concentration using Centricon. Add media to sample filter cup (to a maximum of 70 mL); seal with supplied cap. Place the sample filter cup into filtrate collection cup. Place Centricon Plus-70 assembly in centrifuge bucket.” (p. 17, ¶1). A Centricon device is not a 0.45 µm filter nor a 0.22 µm filter nor does the disclosure of 62213537 imply any method to perform the 0.22 µm filtration and the Centricon filtration as a single-step serial filtration, especially because it is the retentate which is recovered from the Centricon device not the filtrate, i.e., flow through (p. 17, ¶1). Hence, 62213537 clearly DOES NOT explicitly or inherently disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm.
15248629 provides support for filter sterilization of the conditioned media with a single 0.22 µm filter and/or concentration of the conditioned media with Centricon devices wherein the retentate is recovered, but does not explicitly or inherently disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm. Specifically, 15248629 recites “Where applicable in the examples conditioned media may be purified and concentrated according to the following protocol. Collected conditioned media is thawed at 4 °C. Collected lots are pooled and then filtered with a 0.22 micron (µm) filter. Filtered conditioned media is added to sample filter centrifugation cup which is then added to the filtrate collection cup and the combination is placed in a balanced centrifuge. The centrifuge is spun at up to 3500xg until a desired concentration is obtained, typically between 50-90 minutes. Concentrated media may then be transferred from the filtrate collection cup for further application as desired.” (pp. 13-14, spanning ¶). A Centricon device is not a 0.45 µm filter nor a 0.22 µm filter nor does the disclosure of 15248629 imply any method to perform the 0.22 µm filtration and the Centricon filtration as a single-step serial filtration, especially because it is the retentate which is recovered from the Centricon device not the filtrate, i.e., flow through (pp. 13-14, spanning ¶). Hence, 15248629 clearly DOES NOT explicitly or inherently disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm.
17205910 provides support for filter sterilization of the conditioned media with a single 0.22 µm filter and/or concentration of the conditioned media with Centricon devices wherein the retentate is recovered, but does not explicitly or inherently disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm. Specifically, 17205910 recites “Where applicable in the examples conditioned media may be purified and concentrated according to the following protocol. Collected conditioned media is thawed at 4°C. Collected lots are pooled and then filtered with a 0.22 micron (um) sterilizing filter. Filtered conditioned media is added to sample filter centrifugation cup which is then added to the Centricon Plus-70 filtrate collection cup and the combination is placed in a balanced centrifuge. The centrifuge is spun at up to 3500xg until a desired concentration is obtained, typically between 50-90 minutes. Concentrated media may then be transferred from the filtrate collection cup for further application as desired.” [0025]. A Centricon device is not a 0.45 µm filter nor a 0.22 µm filter nor does the disclosure of 17205910 imply any method to perform the 0.22 µm filtration and the Centricon filtration as a single-step serial filtration, especially because it is the retentate which is recovered from the Centricon device not the filtrate, i.e., flow through ([0025]). Hence, 17205910 clearly DOES NOT explicitly or inherently disclose performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm.
Hence, Applicant’s arguments are unpersuasive and the effective filing date of claims 8-12, 17, 25 and 27 is the filing date of the instant application, 7/30/2021.
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 9-11 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 9 recites the limitation "said UC MSCs cell line" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 8 and neither claim 8 or 9 recites a UC MSCs cell line; hence, antecedent basis is lacking for the limitation. NOTE: This rejection can be overcome by amending "said UC MSCs cell line is" to “the UC MSCs are”.
Claim 10 recites the limitation "said conditioned culture medium" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 10 depends from claim 8 and neither claim 8 or 10 recites a conditioned culture medium; hence, antecedent basis is lacking for the limitation. NOTE: This rejection can be overcome by amending "said conditioned culture medium" to “the conditioned medium”.
Claim 11 recites the limitation "said conditioned culture medium" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 11 depends from claim 8 and neither claim 8 or 11 recites a conditioned culture medium; hence, antecedent basis is lacking for the limitation. NOTE: This rejection can be overcome by amending "said conditioned culture medium" to “the conditioned medium”.
Claim 9 comprises an undefined abbreviation, “ULSCs”, which renders the claim indefinite. Abbreviations should be spelled out upon their first occurrence in the claims. NOTE: This rejection can be overcome by amending "ULSCs" to “umbilical cord lining stem cells (ULSCs)”.
Claim Rejections - 35 USC § 103
The rejection of claims 8-10 and 17 under 35 U.S.C. § 103(a) over Riordan et al., US 2012/0195969 (cite A, PTO-892, 10/18/2023; herein “Riordan”) in view of Wun et al., US Patent 5466783 (cite B, PTO-892, 10/18/2023; herein “Wun”), Cox, US 2008/0076706 (cite C, PTO-892, 10/18/2023; herein “Cox”) and/or Xu et al., US 2004/0063132 (cite D, PTO-892, 10/18/2023; herein “Xu”), further in view of Novak et al., US 2007/0092485 (cite E, PTO-892, 10/18/2023; herein “Novak”) as set forth at pp. 7-13 of the previous Office Action is withdrawn in view of the amendment of the claims.
The rejection of claims 8-11 and 17 under 35 U.S.C. § 103(a) over Riordan in view of Wun, Cox and/or Xu, further in view of Novak and Fong et al., US 2015/0352157 (cite F, PTO-892, 10/18/2023; herein “Fong”) as set forth at p. 16 of the previous Office Action is withdrawn in view of the amendment of the claims.
The rejection of claims 8-12 and 17 under 35 U.S.C. § 103(a) over Riordan in view of Wun, Cox and/or Xu, further in view of Novak, Fong and Grabstein, US 7192935 (cite G, PTO-892, 10/18/2023; herein “Grabstein”) as set forth at p. 17 of the previous Office Action is withdrawn in view of the amendment of the claims.
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.
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 8-10 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Riordan et al., US 2012/0195969 (cite A, PTO892, 10/18/2023; herein “Riordan”) in view of Novak et al., US 2007/0092485 (cite E, PTO-892, 10/18/2023; herein “Novak”), Hung et al., US2003/0077682 (cite A, attached PTO-892; herein “Hung”) and Price, US5344920 (cite B, attached PTO-892; herein “Price”).
Riordan teaches producing factor rich compositions from conditioned media of human Wharton’s jelly umbilical cord lining mesenchymal stem cells (ULSCs, UC MSCs) ([0076]; Example 1, [0127]). The factor rich composition is incorporated into a topical cosmetic composition for the treatment of acne [0127-128].
Riordan teaches that the ULSC conditioned medium is produced by a process comprising digesting human Wharton’s jelly with collagenase and culturing the liberated cells in complete media with serum, i.e., isolating a ULSCs cell line; expanding the population of the USLCs cell line in a culture medium containing serum; culturing the cells in medium free of serum and growth factors, which can be for 72 h, i.e., 3 days; collecting and sterile filtering the conditioned medium, i.e., collecting a conditioned culture medium and filtering said conditioned medium ([0076]; Example 1, [0127]; [0065]).
Riordan teaches that the conditioned media can be 1) filtered to remove cellular debris, i.e., aggregates, with any filtration step which removes insoluble matter from a liquid medium [0065] and 2) can be sterile filtered to sterilize the conditioned media ([0127]).
Riordan does not specifically teach that the filtration comprises a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm; however, a person of ordinary skill in the art at the time of filing would have found it obvious that filtering the conditioned media with a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm with a reasonable expectation of success in view of the disclosures of Novak, Hung and Price, common sense, and the general knowledge of filtration and liquid handling that an artisan of ordinary skill in the art would possess.
Novak discloses producing conditioned medium and filtering the conditioned medium through 0.45 and 0.22 micron filters ([0385], [0416], [0420], [0434]).
Hung teaches producing conditioned medium and filtering the conditioned medium sequentially through 3.0 µm and 0.22 µm filters [0015].
Price teaches sequentially filtering conditioned media through 3 filters in a single step wherein the filters are for clarification of the conditioned media and for sterilization of the conditioned media (col. 5, ll. 63-68).
Hence, filtering the conditioned media produced by Riordan sequentially through 3 filters in a single step wherein the first filter is of a larger pore size, i.e., 0.45 µm, to remove aggregates or cell debris, followed by one or more sterilizing filters with a pore size of 0.22 µm, is clearly obvious over the prior art. Filters are not 100% effective, i.e., they could comprise blemishes or manufacturing defects which could allow a small amount of material greater than the nominal pore size through; hence, passing the conditioned media through two sterilizing filters, i.e., two 0.22 µm filters, would guarantee the sterility of the conditioned media.
Additionally, performing the filtration through the 0.45 µm filter then two 0.22 µm filters as a single step is prima facie obvious because it would expedite the process and minimize the number of production steps.
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Riordan in view of Novak, Hung and Price wherein the method comprises preparing a conditioned medium from a ULSCs cell line, collecting the conditioned medium, and performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm with a reasonable expectation of success because Riordan teaches preparing a conditioned medium from a ULSCs cell line, collecting the conditioned medium, and filtering the conditioned media through 0.45 µm and 0.22 µm filters, Hung teaches that the filtration through a larger pore filter and a sterilizing filter, i.e., 0.22 µm filter, can be performed sequentially in a single step, Price teaches filtering conditioned media through 3 filters in a single step, and a person of ordinary skill in the art would recognize that filtration through two sterilizing filters would guarantee that the conditioned media is sterilized; therefore, claims 8-9 and 27 are prima facie obvious.
Regarding claim 10, Riordan teaches that the conditioned media collection can be after 72 h [0065]; hence, collecting the conditioned media every 72 h, i.e., 3 days, is prima facie obvious over Riordan; therefore, claim 10 is prima facie obvious.
Response to Arguments
Applicant's arguments filed 8/19/2025 (and 8/14/2025) have been fully considered but they are not persuasive. Arguments of the Applicant’s Response on pp. 2-4 regarding the rejections under 35 U.S.C. § 103 are moot as the rejections have been withdrawn. However, because Riordan and Novak are relied on in the rejection set forth above, Applicant’s comments regarding Riordan and Novak on pp. 2-3 of the Response are addressed below.
Regarding the rejection under 35 U.S.C. § 103 over Riordan in view of Wun, Cox and/or Xu, further in view of Novak, Applicant argues that Novak does not teach performing such filtration as a single, continuous step (p. 3, full ¶1). The rejection is not an anticipation rejection. Novak repeatedly teaches filtering conditioned medium through a 0.45 µm filter and a 0.22 µm filter as set forth above. Hung clearly teaches the sequential filtration of conditioned media through a 3.0 µm filter and a 0.22 µm filter - a single-step process; and Price teaches the single-step sequential filtration of conditioned media through 3 filters; hence, performing a single-step serial filtration of the conditioned medium sequentially through a first filter having a pore size of about 0.45 μm and subsequently through two filters each having a pore size of about 0.22 μm is prima facie obvious over Riordan in view of Novak, Hung and Price.
Applicant argues that “The proposed motivation-to "expedite the process and minimize the number of steps" -is speculative and not supported by any express teaching in the cited references. There is no showing that this specific combination of filters, particularly in serial within one step, was known or would yield predictable results”. This is unpersuasive in view of the disclosures of Hung and Price. Facilitating the process and minimizing the number of steps in the process are valid motivations for a person of ordinary skill in the art at the time of filing. Applicant’s conjecture that doing the filtrations as a single step is speculative and not supported by any express teaching in the art is clearly disproven with Hung and Price. Applicant’s assertion that doing the filtration serially as a single step would somehow yield unpredictable results is unpersuasive.
Applicant argues “Moreover, none of the cited references addresses the effect of this filtration method on the integrity or bioactivity of the conditioned medium, which is a critical limitation of Applicant's claims. Thus, hindsight appears to be impermissibly used to reconstruct Applicant's invention based on the problem and solution described in the specification.” (p. 3, full ¶2).
Applicant has not shown how filtering the conditioned media serially as a single step would somehow be unpredictable. Filters filter in a known, predictable way regardless of whether they are in series or not. Applicant has not shown any evidence or reasoning to the contrary; hence, Applicant’s argument is unpersuasive.
Applicant alleges that the rejection uses impermissible hindsight (p. 3). 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.
Claims 8-11, 17 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Riordan in view of Novak, Hung, Price and Fong et al., US 2015/0352157 (cite F, PTO-892, 10/18/2023; herein “Fong”).
The discussion of Riordan, Novak, Hung and Price regarding claims 8-10 and 27 set forth in the rejection above is incorporated herein.
Riordan, Novak, Hung and Price do not disclose whether the filtration was vacuum filtration, gravity filtration, syringe filtration or tangential flow filtration. However, a person of ordinary skill in the art at the time of filing would have found it obvious for the filtration in the method made obvious by Riordan in view of Novak, Hung and Price to be syringe filtration in view of the disclosure of Fong.
Fong teaches producing conditioned medium from UC MSCs which are ULSCs (Abst.). Fong teaches that the UC MSC conditioned medium was sterile filtered with a 0.22 µm Millex-GP syringe filter [0114].
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Riordan in view of Novak, Hung and Price with the filtration being syringe filtration in view of the disclosure of Fong that UC MSC conditioned medium can be sterile filtered by syringe filtration; therefore, claims 11 and 17 are prima facie obvious. It is noted that syringe filters commonly have Luer-lock ports on the inlet and outlet; hence, connecting 3 syringe filters in series to a syringe is clearly prima facie obvious because they have been manufactured to allow such a configuration.
Response to Arguments
Regarding the rejection of claim 11 under 35 U.S.C. 103 over Riordan in view of Wun, Cox and/or Xu, further in view of Novak and Fong, Applicant argues that “Combining Riordan with Fong lacks a reasonable expectation of success that the biological efficacy of the product would be maintained.” (p. 3, ¶5). Fong is also purifying conditioned media from a ULSCs cell line (Wharton’s jelly mesenchymal stem cells); hence, Applicant’s argument is unpersuasive.
Claims 8-12, 17, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Riordan in view of Wun, Cox and/or Xu, further in view of Novak, Fong and Grabstein, US 7192935 (cite G, PTO-892, 10/18/2023; herein “Grabstein”).
The discussion of Riordan, Novak, Hung, Price and Fong regarding claims 8-11, 17 and 27 set forth in the rejection above is incorporated herein.
Riordan, Novak, Hung and Price do not disclose whether the filtration was with polyethersulfone (PES), polyvinylidene fluoride (PVDF), mixed cellulose esters, cellulose acetate or cellulose nitrate filters. However, a person of ordinary skill in the art at the time of filing would have found it obvious for the filtration in the method made obvious by Riordan in view of Novak, Hung, Price and Fong to be with cellulose acetate filters in view of the disclosure of Grabstein.
Grabstein teaches producing conditioned medium and filtering the conditioned medium through 0.22 µm cellulose acetate filters because cellulose acetate filters do not bind protein (Example 1, col. 21, l. 66 – col. 22, l. 12).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Riordan in view of Novak, Hung, Price and Fong with cellulose acetate filters because Grabstein teaches that cellulose acetate filters do not bind protein; therefore, claims 12 and 25 are prima facie obvious.
Response to Arguments
Regarding the rejection of claim 12 under 35 U.S.C. 103 over Riordan in view of Wun, Cox and/or Xu, further in view of Novak, Fong and Grabstein, Applicant argues that “Grabstein's disclosure of cellulose acetate filters to avoid protein binding is context-specific and not directed to filtering UC MSC-derived conditioned medium. The Examiner has not established that the choice of cellulose acetate filters would have been obvious in the claimed context, especially given concerns over yield loss or molecular retention during such filtration.” (p. 3, last ¶). Cellulose acetate filters having low protein binding is NOT context specific, it is a property of the cellulose acetate filters. What Applicant means by “context-specific” is unclear and not based on any evidence or reasoning. Concerns over yield loss or molecular retention is exactly why one would choose cellulose acetate filters with low protein binding; hence, Applicant’s argument appears circular or non-sensical. Clearly it is prima facie obvious to choose filters with low protein binding, such as cellulose acetate filters, in order to minimize yield loss or molecular retention; hence, Applicant’s arguments are unpersuasive.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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