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 1-20 are pending.
Priority
Acknowledgement is made of Applicants’ claim for benefit under 35 USC 121 as a divisional of prior-filed US Appln No. 16/321075 (now USP 12157899), which is a national stage entry of PCT/US2017/022257 (filed 3/14/2017), which claims benefit of prior-filed US Provisional Appln Nol 62/307629 (filed 3/14/2016).
However, the instant application is an improper divisional, and thus will not get the ‘121 shield’ over the parent application/patent (US application 16/321075). The restriction requirement was withdrawn in its entirety in the parent application in the action dated 8/2/2024. Furthermore, at least claims 1, 2, 6 and 7 are identical to those originally examined in the parent application. Thus the instant application is not a proper divisional as it does not present only claims drawn to non-elected inventions from the parent application. Applicants are required to correct the priority claim of the instant application by filing a new ADS, wherein under “domestic priority” the word “divisional” is lined through and the word “continuation” is written in and underlined.
Claim Objections
Claims 4, 5, 9-15, 19 and 20 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 4, 5, 9-15, 19 and 20 have not been further treated on the merits.
Claim Interpretation
The term “placental tissue” is defined by the instant application as including the placental disc, the amniotic sac, and umbilical cord, [umbilical cord] vessels and Wharton’s jelly” (See ¶0019 of PGPub). The specification makes further note that the term “placental tissue” comprises (understood to mean ‘includes, but is not limited to’) chorion frondosum tissue, decidua basalis tissue, and/or interconnecting tissue, which may be in whole or in part (See ¶0025). The specification teaches that the placental composition may be a cell free composition that comprises one or more growth factors and/or cytokines from the placental tissues (See ¶0031). The specification teaches the placental composition cane be derived from tissues and/or cells from any of the placental tissues (See ¶0034). Thus, the broadest reasonable interpretation of “placental tissue” will encompass multicellular tissues pieces, as well as individual cells from placental tissues, as well as molecules (e.g. proteins, growth factors, cytokines) and/or extracts derived from placental cells and/or extracellular matrix of placental tissue.
In claim 3 the ‘villous chorion’ is understood to refer to a portion of the placental disc (as opposed to the chorionic membrane, which is part of the amniotic sac).
Claim 6 appears to attempt to use product-by-process language, but the claim does not use appropriate language to limit the claimed placental preparation to be prepared by a process comprising homogenization and cell lysis. The broadest reasonable interpretation of claim 6 is that the claim is drawn to a placental preparation comprising a placental tissue and one or more protease inhibitors, wherein the placental tissue is capable of being processed by homogenization and cell lysis. Claims 7-8 are similarly deficient, the broadest reasonable interpretation of claims 7-8 being identical to the BRI of claim 6. It would be remedial to amend the language of claim 6 to read “A placental preparation comprising a placental tissue and one or more protease inhibitors, wherein the placental tissue is produced by a process comprising
For compact prosecution, claims 6-8 will also be considered as if they did recite proper product-by-process language. Product-by-process limitations are only considered in so far as the process of production affects the final structure of the product. In the instant case, there is no order required amongst the homogenization and cell lysis in claim 6. It is noted that homogenization will reasonably be expected to lyse at least some cells. The effect of the process steps recited in claim 6 on the final product will be: a homogenized placental tissue in which at least some cells are lysed. However, in light of dependent claims which require further separation of lysed cells and filtration, and noting that claim 6 uses open language “comprising”, the product covered by claim 6 may be further processed beyond the homogenization and lysing steps. Specifically, the product covered by claim 6 may be a supernatant or filtrate produced from the homogenized and lysed tissue. In claim 7 the step of separating lysed cells must be carried out after the cell lysis step, but the homogenization and lyophilization and/or freezing may be carried out in any order. It is noted that freezing will necessarily lyse at least some cells. The physical product generated by the process steps recited in claim 7 may be any of: (1) frozen or lyophilized separated lysed placental cells, (2) non-frozen, non-lyophilized separated lysed placental cells, (3) frozen or lyophilized homogenized placental tissue from which cells have been removed, (4) non-frozen, non-lyophilized homogenized placental tissue, from which cells have been removed, (5) frozen or lyophilized non-cellular, non-tissue fraction (i.e. extract) of homogenized placental tissue, or (6) non-frozen, non-lyophilized non-cellular, non-tissue fraction of homogenized placental tissue. In claim 8, it is unclear how the filtration step falls in line with any of the previously recited steps. Any placental product that has had at least one component removed therefrom, or which is a component which has been removed, will be considered to meet the physical requirement of claim 8.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3 and 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature judicial exception without significantly more.
Regarding claim 1: The claim is to a placenta-derived composition comprising placental tissue and one or more protease inhibitors. Amniotic membrane is a placental tissue. As evidenced by Kim et al (Exp Eye Research, 2000), amniotic membrane contains several protease inhibitors, including α1-antichymotrypsin, α2-macroglobulin, α1-antitrypsin, α2-antiplasmin, and inter-α1-trypsin inhibitor (See Kim et al, Pg. 330, col. 1). Additionally, chorion is a placental tissue. As evidenced by Tom et al (US 2015/0010609) chorion contains protease inhibitors TIMP1 (See ¶0302) and α2-macroglobulin (See ¶0300). Therefore claim 1 reads on each of natural amniotic membrane and chorion tissue. Each of natural amniotic membrane and chorion tissue are product of nature judicial exceptions. This judicial exception is not integrated into a practical application because the claim recites no further limitations that incorporate or apply the product of nature judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim requires no additional elements.
Regarding claims 6-8: This rejection is made over the broadest reasonable interpretation of claims 6-8, which is “A placental preparation comprising a placental tissue and one or more protease inhibitors” (i.e. wherein claim 6 is not considered a proper product-by-process claim). Thus claims 6-9 read on natural amniotic tissue and/or natural chorion tissue. Each of natural amniotic membrane and chorion tissue are product of nature judicial exceptions. This judicial exception is not integrated into a practical application because the claim recites no further limitations that incorporate or apply the product of nature judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim requires no additional elements.
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 7-8 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.
This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. Claims 7-8 would further limit the processing steps.
For the reasons discussed above under “Claim Interpretation” there is no order recited amongst the processing steps of claims 7 or 8.
In claim 7 it is therefore not clear if lyophilization and/or freezing is the last step, and thus the placental preparation must be lyophilized or frozen, or if the lyophilization and/or freezing may occur earlier in the processing and the placental preparation is thawed. Furthermore, it is not clear what is recovered after the ‘separation of lysed cells’ (the lysed cells & contents thereof? or the remaining tissue?). As written, claim 7 permits for multiple different interpretations of the final claimed product, thus the metes and bounds of what is being claimed cannot be determined.
Likewise, in claim 8, it is not clear when the filtration is to occur in comparison to the steps of parent claims 6 or 7. Furthermore, it is not clear how the filtration step falls in with the steps of parent claims 6 or 7, thus it cannot be determined what is ultimately required by claim 8. The metes and bounds of claim 8 cannot be determined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jansen et al (WO 15/171142), in light of Varney’s Midwifery, 4th ed (2004) and Sigma Aldrich Product Information for #04693124001 Roche cOmplete™, Mini Protease Inhibitor Cocktail.
Jansen et al disclose therapeutic placental compositions comprising placental cells and other placental components derived from placental tissue (See abstract, ¶0008). The placental cells and placental components are produced by obtaining a placental tissue, exposing the placental tissue to at least one collagenase for a time sufficient to release placental cells, isolating the released placental cells from the collagenase exposed placental tissue, mechanically disrupting (e.g. homogenizing) the remaining collagenase exposed placental tissue to create a placental dispersion, and combining the placental cells and the placental dispersion to form a placental product (See ¶0018-0019, Example 2 ¶00230-00236). In some embodiments the placental composition can be cryopreserved and then thawed, wherein at least 40% of the cells are viable post thaw (See ¶0020). Noting that as few as 40% of the cells survive post cryopreservation, it is clear the cryopreservation results in lysis of at least some cells (dead cells will eventually lyse).
The placental tissue may be, inter alia, chorion, amnion, placental cotyledons, and/or combinations thereof (See ¶0075).
The therapeutic placental composition can further comprise one or more therapeutic factors (See ¶0010). The one or more therapeutic factors can be provided prior to cryopreservation (See ¶0022). The therapeutic factors may be, inter alia, protease inhibitors (See ¶0085, 0119-0122).
The therapeutic placental composition can be combined with a carrier to form a composition. The carrier may be a biocompatible scaffold (See ¶0218).
The general disclosure of Jansen et al reads on the claims as follows:
Regarding claim 1: Jansen et al teach a composition that can comprise placental cells and placental components (each of which satisfy the definition of placental tissue of the instant application) and one or more therapeutic factors, wherein the therapeutic factor can be protease inhibitors.
Regarding claim 3: Jansen et al teach the placental tissue from which the placental cells and placental components can be derived include the chorion, and specifically placental cotyledons. The placental cotyledons consist of villous chorion (See Varney’s Midwifery, Pg. 565, 2nd col, last full paragraph).
Regarding claims 6-8: This rejection is made over the broadest reasonable interpretation of claims 6-8, which is “A placental preparation comprising a placental tissue and one or more protease inhibitors” (i.e. wherein claim 6 is not considered a proper product-by-process claim): Jansen et al teach a composition that can comprise placental cells and placental components (each of which satisfy the definition of placental tissue of the instant application) and one or more therapeutic factors, wherein the therapeutic factor can be protease inhibitors.
Regarding claim 6: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps: Jansen et al teach the therapeutic placental composition contains placental tissue which has been subject to homogenization. Homogenization will serve to lyse at least some cells. Furthermore, Jansen et al teach the homogenized placental tissue can be subject to cryopreservation, cryopreservation will further cause death, and thus lysis, of at least some cells (up to 60%). Therefore the final composition, which is a mixture of placental cells, placental tissue homogenate, and protease inhibitors, will meet the physical limitations implied by the product-by-process limitations of claim 6.
In Example 27, Jansen et al disclose a process for measuring VEGF levels in chorion membrane tissue. This process involves obtaining chorionic membrane from placenta, digesting the chorionic membrane with dispase, scraping off the trophoblast layer (from Example 1), mincing the chorionic membrane, mixing the minced tissue with saline, cryopreserving the mixture (from Example 4), thawing the mixture, centrifuging to separate the supernatant from tissue/cell pellet, snap freezing the tissue/cell pellet, adding Guanidine HCl + Roche cOmplete™, Mini Protease Inhibitor Cocktail (catalog # 04693124001) and lysis bead, lysing the tissue/cell pellet, recombining the lysed tissue/cell pellet with the supernatant, centrifuging the resulting mixture and collecting the supernatant, and desalting the supernatant (See ¶00324-00327).
The supernatant recovered in Example 27 reads on the claims as follows: Regarding claim 1: The supernatant contains factors from chorionic membrane (which satisfies the definition of placental tissue of the instant application) as well as protease inhibitors from the Roche cOmplete™ Mini Protease Inhibitor Cocktail (noting that there is no step of removing the protease inhibitors).
Regarding claim 2: The Roche cOmplete™ Mini Protease Inhibitor Cocktail contains a proprietary mix of protease inhibitors, but the product information sheet does identify that it contains EDTA, which is one of the recited species in claim 2 (See Sigma Product info sheet for Roche protease inhibitor cocktail).
Regarding claim 6: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. Noting that claim 6 uses open transitional language “comprising” the processing of the placental tissue may include additional steps, which may ultimately result in a product comprising supernatant from processed placental tissue, no tissue remnants, and no lysed cell remnants. The supernatant fraction ultimately obtained in Example 27 meets these physical limitations and thus reads on placental tissue. The presence of residual protease inhibitors from the Roche cOmplete™ Mini Protease Inhibitor Cocktail (noting that there is no step of removing the protease inhibitors) reads on protease inhibitors.
Regarding claim 7: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. The additional processing steps of claim 7 will result in any of: (1) frozen or lyophilized separated lysed placental cells, (2) non-frozen, non-lyophilized separated lysed placental cells, (3) frozen or lyophilized homogenized placental tissue, from which cells have been removed, (4) non-frozen, non-lyophilized homogenized placental tissue, from which cells have been removed, (5) frozen or lyophilized non-cellular, non-tissue fraction of homogenized placental tissue, or (6) non-frozen, non-lyophilized non-cellular, non-tissue fraction of homogenized placental tissue. The supernatant fraction ultimately obtained in Example 27 meets the physical limitation of (6) non-frozen, non-lyophilized non-cellular, non-tissue fraction of homogenized placental tissue. As there is no tissue fraction present, the fact that the method does not involve homogenization does not distinguish the final product. It is noted that the cryopreservation/thaw, and freezing/thawing steps carried out in Example 27 will result in lysis of some cells.
Regarding claim 8: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. The supernatant fraction ultimately obtained in Example 27 is identical to a fraction which may be obtained by filtration (if the cell pellet + supernatant were passed through a filter, and the filtrate (supernatant) was recovered).
Claims 1, 2, 6-8 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tseng et al (US 2007/0071740), in light of Sigma Aldrich Product Information for P8340 Protease Inhibitor Cocktail.
Tseng et al disclose extracts from amniotic membrane for therapeutic purposes (See abstract). Tseng et al disclose preparation of the amniotic membrane extract (AME) by:
obtaining fresh or frozen placentas,
slicing the amniotic membrane into small pieces,
pulverizing the amniotic membrane pieces under liquid nitrogen to generate a fine powder,
mixing the powder with PBS, protease inhibitor cocktail P8340 from Sigma, supplemented with PMSF and phosphatase inhibitors,
homogenizing the mixture to generate “Total” AM extracts (AME) (See ¶0095).
The AME were then subject to centrifugation,
the supernatants were recovered (AM/HS, AM/LS),
the supernatants were lyophilized,
the supernatants were reconstituted with distilled H2O (See ¶0096).
Regarding claim 1: The AME reads on a placenta-derived composition, as the amniotic membrane homogenate reads on placental tissue, and the residual protease inhibitors read on one or more protease inhibitors.
Alternatively, the supernatant recovered from the AME (the AM/HS and/or AM/LS) read on placental-derived compositions, as the amniotic membrane extract reads on placental tissue (within the definition of the instant application), and the residual protease inhibitors (which will be present in the recovered supernatant, by virtue of them being in solution), read on one or more protease inhibitors.
Regarding claim 2: The AME contains P8340 protease inhibitor cocktail from Sigma, which includes AEBSF, aprotinin, and leupeptin (See Sigma product information sheet for P8340), the AME further comprises protease inhibitor PMSF.
The AM/HS and/or AM/LS also contain the same protease inhibitors.
Regarding claim 6: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. The placental tissue first obtained by Tseng et al was frozen. It is further subject to pulverization under liquid nitrogen. The freezing and pulverizing steps will necessarily result in lysis of at least some cells. The amniotic membrane tissue is then homogenized. Thus the AME has been processed by homogenization and cell lysis. The resulting AME meets the physical limitations achieved by these two steps. The AME further contains protease inhibitors.
Regarding claim 7: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. The additional processing steps of claim 7 will result in any of: (1) frozen or lyophilized separated lysed placental cells, (2) non-frozen, non-lyophilized separated lysed placental cells, (3) frozen or lyophilized homogenized placental tissue, from which cells have been removed, (4) non-frozen, non-lyophilized homogenized placental tissue, from which cells have been removed, (5) frozen or lyophilized non-cellular, non-tissue fraction of homogenized placental tissue, or (6) non-frozen, non-lyophilized non-cellular, non-tissue fraction of homogenized placental tissue. Following the discussion of claim 6 above, the AME is subjected to conditions that will result in cell lysis and homogenization. The AM/HS and/or AM/LS is the supernatant of the AME. The supernatant is separated from the residual cells and cell lysis components of the AME. The AM/HS and AM/LS are then further lyophilized. The lyophilized AM/HS and/or lyophilized AM/LS reads on (5) frozen or lyophilized non-cellular, non-tissue fraction of homogenized placental tissue. The reconstituted AM/HS and/or reconstituted AM/LS reads on (6) non-frozen, non-lyophilized non-cellular, non-tissue fraction of homogenized placental tissue.
Regarding claim 8: This rejection is made for the interpretation as if claim 6 were written as a proper product by process claim, and required the placental preparation to be produced by the recited processing steps. The AM/HS and/or AM/LS are identical to fractions which may be obtained by filtration (if the cell pellet + supernatant were passed through a filter, and the filtrate (supernatant) was recovered).
Regarding claim 16: The powdered amniotic membrane is considered to read on placental tissue. The step of adding the protease inhibitor cocktail P8340 supplemented with PMSF and phosphatase inhibitors to the powered amniotic membrane reads on (1) adding protease inhibitors to placental tissue. The step of homogenizing the mixture to generate AME reads on (2) homogenizing the placental tissue. The homogenization step will also necessarily serve to (3) lyse the placental tissue. The lyophilized final supernatant reads on the placental product.
Regarding claim 17: the step of centrifuging the AME and recovery of the supernatant results in separation of lysed cells. The step of lyophilizing the supernatant reads on lyophilizing the product.
Claims 1-3, 6-8 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmed et al (J Clin Endrocrin Metab, 2000).
Ahmed et al study molecular forms of CRH in normal and preeclamptic placenta (See paragraph spanning pg 755-756).
Ahmed et al obtain placentas from normal term pregnancies and from preeclamptic pregnancies (See Pg 756 “Experimental subjects”). Ahmed et al obtain tissue extracts from the placental chorionic villi by: rinsing the villous tissue with PBS; homogenizing the tissue with one of 1) RIPA buffer containing protease inhibitors PMSF, antipain, chymostatin, pepstatin A, aprotinin and leupeptin, 2) RIPA buffer alone, or 3) PBS alone, to generate extracts; the extracts were centrifuged; supernatants recovered; and stored at -70oC (See Pg 756 “Tissue extraction”). Ahmed et al test the levels of CRH and pro-CRH in the tissue extracts (See Pg 756-757 “Gel filtration chromatography”).
The tissue extract of Ahmed et al, specifically that extracted with treatment 1) RIPA buffer + protease inhibitors, reads on the current claims as follows:
Regarding claims 1-3: Following extraction in the RIPA buffer + protease inhibitors, Ahmed et al centrifuge the extract and recover the supernatant. Cells and insoluble cell debris will be present in the precipitate fraction, the supernatant will contain the acellular fraction, as well as the protease inhibitors used in extraction. Thus the recovered supernatant reads on a placental tissue and one or more protease inhibitors (including leupeptin, PMFS and aprotinin). The extracts are from the chorionic villi of placenta. The chorionic villi is part of the placental disc and is synonymous with villous chorion. Thus the extracts are of placental tissue, wherein the placental tissue comprises a villous chorion.
Regarding claims 6-7: Following the discussion of claim 1 above, the recovered supernatant extracted with treatment 1) RIPA buffer + protease inhibitors comprises placental tissue and protease inhibitors. Thus the extracts are placental preparations comprising placental tissue, wherein the placental tissue comprises a villous chorion.
As discussed in the Claim Interpretation section, the process of production is considered only in so far as the process affects the structure/composition of the final product. Yet, it is noted that the method of Ahmed et al does read on the particular processing steps of claim 6, specifically:
the chorionic villus tissue is homogenized in the presence of exogenous protease inhibitors (which means the exogenous proteases are added prior to homogenization);
homogenization will necessarily lead to cell lysis, thereby creating a solid cellular debris and an acellular fluid;
centrifugation serves to separate the acellular fluid (containing the protease inhibitors) from the solid cellular debris;
and the acellular fluid is collected.
Though claim 6 does not require the overall preparation to be frozen or lyophilized, Ahmed et al does freeze the acellular fluid (containing the acellular extract of placental tissue and exogenous protease inhibitors).
Regarding claim 8: The additional process step of claim 8 does not further limit or distinguish the placental preparation from that acellular extract of Ahmed et al.
Regarding claims 16-17: Following the discussion of claims 6 and 7 above, Ahmed et al teach:
homogenizing the chorionic villus tissue in the presence of exogenous protease inhibitors (which means the exogenous proteases are added prior to homogenization, this reads on adding protease inhibitors to the placental tissue);
homogenization will necessarily lead to cell lysis, thereby creating a solid cellular debris and an acellular fluid;
centrifugation serves to separate the acellular fluid (containing the protease inhibitors) from the solid cellular debris;
collecting the acellular fluid; and
freezing the acellular fluid.
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.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng et al (US 2007/0071740), in light of Sigma Aldrich Product Information for P8340 Protease Inhibitor Cocktail.
The teachings of Tseng et al are set forth above.
Regarding claim 18: Tseng et al differs in that Tseng et al do not teach further filtering the lyophilized supernatant (placental product). However, Tseng et al do teach reconstituting the lyophilized supernatant for use. It would have been prima facie obvious to have filtered the reconstituted supernatant in order to remove any undissolved clumps. Doing so would read on filtration. One would have been motivated to do so in order to remove any undissolved clumps. One would have had a reasonable expectation of success because filtration was a well-known technique at the time the application was filed.
Claims 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmed et al (J Clin Endrocrin Metab, 2000).
The teachings of Ahmed et al are set forth above.
Regarding claim 18: Ahmed et al differs in that Ahmed et al do not teach further filtering the frozen acellular fluid (placental product). However, in order to use the fluid, it would eventually need to be thawed, and at that point in time it would have been prima facie obvious to have filtered the thawed fluid in order to remove any residual clumps. Doing so would read on filtration. One would have been motivated to do so in order to remove any residual clumps. One would have had a reasonable expectation of success because filtration was a well-known technique at the time the application was filed.
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 1-3, 6-8 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12157899.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Patented claim 1 anticipates instant claims 1-3, noting that the placental disc comprises villous chorion.
Patented claim 9 anticipates instant claims 6-8.
Patented claim 18 anticipates instant claims 16-18.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 , and 4 of copending Application No. 18/690229 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims recite administration of a composition which anticipates the currently claimed composition. Disclosure of use of a composition necessarily renders obvious the composition, per se.
Reference claim 1 recites a placenta-derived composition comprising placental tissue and one or more protease inhibitors. This anticipates the composition of current claim 1.
Reference claim 4 teaches the protease inhibitors of current claim 2.
Reference claim 2 states the placental tissue comprises a placental disc, which includes villous chorion., and thus anticipates current claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of copending Application No. 18/690211 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims recite administration of a composition which anticipates the currently claimed composition. Disclosure of use of a composition necessarily renders obvious the composition, per se.
Reference claim 1 recites a placenta-derived composition comprising placental tissue and one or more protease inhibitors. This anticipates the composition of current claim 1.
Reference claim 4 teaches the protease inhibitors of current claim 2.
Reference claim 2 states the placental tissue comprises a placental disc, which includes villous chorion., and thus anticipates current claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALLISON M FOX/Primary Examiner, Art Unit 1633
