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 .
Claims 21,29-32 are under examination.
Response to Applicants’ Instant Set of Claims/Arguments
The examiner has considered applicants’ arguments and amendments. The examiner agrees with applicants that Sinclair does not teach the homogenization/milling of the chorion. Therefore, this action is made non-final. The examiner has withdrawn the former rejections and put forth new rejections. Because of the claim amendments, the claim objections are removed.
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.
Claims 21, 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over LeVaughn (US 20190350983) in view of Tseng (US 20150342998), Daniel (US 2014001728), and Imhof (US 20160166737)
LeVaughn teaches a method for preparing a pharmaceutical composition for point of care medical treatment, comprising the steps of (1) separating amniotic membrane, chorionic membrane, and umbilical cord from placental tissue (Paragraphs 12, 14 and 48 of LeVaughn). LeVaughn teaches that once the separated amniotic membrane, chorionic membrane, and umbilical cord have been decontaminated and rinsed, they are combined into one mixture and further lyophilized (Paragraph 64).
LeVaughn does not teach that the separated amniotic, chorionic, and umbilical cord material are broken into pieces, milled, or sieved. However, Tseng teaches that its placental material can be morselized by a milling operation to yield morsels ranging from 0.1 mm to about 1.0 cm (Paragraph 27 of Tseng). Such morsels can be subsequently lyophilized (Paragraphs 27,31-33 of Tseng). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have milled LeVaughn’s placental material using the method of Tseng. An artisan would have been motivated to have used Tseng’s milling operation to morselize tissue followed by a lyophilization operation because it creates particles that can be successfully administered to a patient in need (Paragraphs 10 and 12,15-16,67-70 of Tseng). Because Tseng’s method of particle fabrication results in particles that can be easily administered (Paragraphs 67-70), there would be a high expectation for success milling and lyophilizing the LeVaughn product to make a product that can be easily administered to a subject.
Neither LeVaughn or Tseng teach sieving the placental product after the milling operation. However, Imhof teaches sieving of a milled product (Paragraphs 42,47-49 of Imhof) wherein the milled product can be derived from placental material (Paragraphs 18 and 32 of Imhof). It would have been obvious to an artisan of ordinary skill in the art to have used the sieving operation taught in Imof with the processes taught in LeVaughn and Tseng. An artisan would have been motivated to have used such a sieving operation in order to separate out particulate material from the milled material (Paragraph 44, 47-49 of Imhof). Because sieving is able to break down the milled material to a smaller particles, there would have been a high expectation for success (Paragraphs 44,47-49 of Imhof)
LeVaughn teaches the amniotic membrane and umbilical cord concentrations recited in the instant claims. However, LeVaughn fails to teach the concentration of chorionic membrane recited in the claims. Daniel teaches the recited concentrations of amniotic membrane, chorionic membrane, and umbilical cord used in a therapeutic placental particulate preparation (Paragraph 59 of Daniel). Daniel specifically states that the amount of amniotic membrane can be in the range of 10-50%, the amount of chorionic membrane can be in the range of 20-60%, and the amount of Wharton’s jelly/umbilical cord can be present in the range of 20-60% of the placental particulate mixture (Paragraph 59 of Daniel).
It would have been obvious to an artisan of ordinary skill at the time of effectively filing to have made a particulate placental composition using the amount of chorionic membrane, amniotic membrane, and umbilical cord taught by Daniel. LeVaughn teaches that its composition can be used to treat cosmetic concerns such as wrinkles and scars (Paragraph 3 of LeVaughn). An artisan would have been motivated to have specifically used the concentrations of amniotic membrane, chorionic membrane, and umbilical cord taught by Daniel because those concentrations have been present in a placental particulate composition used to treat scars (Paragraph 82 of Daniel). Because the particulate formulation of Daniel is able to treat scars, a cosmetic concern, (Paragraph 82 of Daniel), there would be a high expectation for success as in instant Claim 21.
Dependent Claims taught by LeVaughn
LeVaughn teaches wherein the amniotic membrane, the chorionic membrane, and umbilical cord particulate are obtained from mammalian placental tissue (Paragraph 43 of LeVaughn) as in instant Claim 29. LeVaughn teaches rehydrating the mixture to form a suspension (Paragraphs 72-76) as in instant Claim 30. LeVaughn teaches wherein the suspension comprises a minimum of 10 mg/ml of particulates (Paragraph 73) as in instant Claim 31.
Dependent Claims taught by Tseng
Tseng teaches that the particulates are obtained from mammalian placental tissue (Paragraphs 5 and 23 of Tseng) as in instant Claim 29. Tseng teaches rehydrating the mixture to form a suspension (Paragraphs 32-33 of Tseng) as in instant Claim 30.
In Regards to Claim 32—LeVaughn teaches that the placental particulate composition can include factors such as FGF (fibroblast growth factor) (Paragraph 15 of LeVaughn) and fibronectin (Paragraph 11 of LeVaughn). Daniel teaches that its composition can release fibronectin (Paragraphs 63 of Daniel). Combining the method steps of LeVaughn, Tseng, and Imhof as discussed above and using the amniotic membrane, chorionic membrane, and umbilical cord concentrations taught by Daniel would result in a composition that comprises quantifiable amounts of the following factors: FGF, IL-1Ra, IL-1α, TIMP-1, TIMP-2, TIMP-3, and fibronectin.
LeVaughn teaches a method of preparing a pharmaceutical by separating components of placenta (amnionic membrane, chorionic membrane, and umbilical cord), and then subsequently combining these components into a mixture to undergo subsequent lyophilization. LeVaughn does not teach that when the amniotic membrane, chorionic membrane, and umbilical cord are separated, they are broken down into smaller pieces by milling/sieving and subsequently lyophilized. However, an artisan would have been motivated to have incorporated the milling treatments taught by Tseng for each placental component because these individual treatments further break down the separated placental components so that they can be further processed into a therapeutic placental particulate composition. Neither LeVaughn or Tseng teach a sieving operation; however, Imhof teaches that sieving can be used after a milling operation to break apart the milled material (Paragraphs 42,47-49 of Imhof). LeVaughn fails to teach all concentrations of amniotic membrane, chorionic membrane, and umbilical cord recited in the claims. However, Daniel teaches ranges that include concentrations recited in the claims for the concentrations of amniotic membrane, chorionic membrane, and umbilical cord material. An artisan would have been further motivated to have used the concentrations taught in Daniel because they can be successfully used in a placental particulate composition to treat conditions such as scars and wrinkles. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
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 combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology and placental implant preparation. Therefore, the level of ordinary skill in this art is high.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21,29-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-34 of copending Application No. 18,608,371(reference application) in view of Imhof (US 20160166737). Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claim 21 and claim 29 of Application 18/608,371 recite a method of separating the amnion, chorion, and umbilical cord from placenta. Each distinct portion is then individually cut into pieces, milled, and lyophilized before being combined back with the other portions to form a mixture. The instant mixture is composed of about 10 wt% to about 30 wt% amniotic membrane particulates, about 30 wt% to about 75 wt% chorionic membrane particulates, and about 5 wt% to about 50 wt% umbilical cord particulates. The instant claims and the claims of 18/608,371 only have slight differences between them. The instant claims recite that the amnion, chorion, and umbilical cord particulates have a particle size of about 20 to about 150 microns which is produced by a milling operation (because of the small size of the particles, this would considered cryomilling). The placental particles mentioned in claim 29 of Application 18/608,371 have a particle size of 20 to about 150 microns which would also be indicative of cryomilling. The claims of 18,608,371 do not teach sieving milled placental material; however, Imhof teaches that sieving can be done on milled placental material in order to separate out the milled material.
Instant claim 29 corresponds to the limitation in claim 29 of Application 18/608,371. Instant Claim 30 corresponds to claim 30 of Application 18/608,371. Both instant claim 31 and claims 31-33 of 18/608,371 disclose placental particulate concentrations in the compositions. The range of placental particulate concentrations recited in the instant claims and the ranges of placental particulate concentrations in Application 18/808,371 overlap. It would have been obvious for an artisan to have adjusted the particulate range as needed. Instant claim 32 corresponds to claim 34 of Application 18/608,371. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638