Detailed Action
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1-148 are cancelled. Claims 166-170 are new. Claims 149, 153, 155, 156, and 160 are currently amended. Claims 149-170 are currently pending and under examination.
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. Claims 149-170 have an earliest effective filing date of 07/11/2012, corresponding to provisional application 61/670571.
Information Disclosure Statement
Information Disclosure Statements filed on 04/21/2023 and 01/29/2025 have been considered.
Response to Remarks filed 01/12/2026
Regarding the 35 USC 112a rejection Applicant’s arguments and amendments have been fully considered and are persuasive. Specifically, amending claim 149 to include "...wherein a tumor microenvironment of the cancer comprises macrophages...." overcomes the rejection. Therefore, the 35 USC 112a rejection is withdrawn.
Regarding the 35 USC 102 rejections, Applicant’s arguments and amendments have been fully considered and are not persuasive. Specifically, amending the claim to include "...wherein a tumor microenvironment of the cancer comprises macrophages...." does not overcome the rejection. Regarding claims 167-170 Tseng et al further teach that the preparations may be used in the treatment of various cancers including prostate cancer, colorectal cancer, liver cancer, kidney cancer, bladder cancer, brain cancer, ovarian cancer, lung cancer, melanoma, breast cancer, thyroid cancer, pancreatic cancer, stomach cancer, lung cancer, leukemia, lymphoma, sarcomas, gastric cancer, bone cancer, oral cancer, eye cancer, or carcinoma (Tseng et al, pg. 39, paragraph 00260) and that the treatment can be used against fibroblasts (Tseng et al, pg. 38, paragraph 00254) and macrophages (Tseng et al, pg. 40, paragraph 00262-00265), which is significant, because it is well-known in the art that the tumor microenvironment often includes tumor-associated macrophages (TAMs) and cancer-associated fibroblasts. As such the method of Tseng et al would often be performed in individuals having TAMs and cancer-associated fibroblasts in the tumor microenvironment. Furthermore, regarding claims 166 and 167, Tseng et al teach the treatment may be used in combination with other therapies (Tseng et al, pg.32, paragraphs 00223-00231). Therefore the 35 USC 102 rejection is maintained, and newly added claims 166-170 are included in the rejection.
Regarding the Double Patenting rejection, Applicant’s amendments and arguments have been fully considered and are not persuasive for the reasons discussed above. Therefore, the Double patenting rejection is maintained.
Rejections Maintained- Nonfinal 07/14/2025
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 149-165 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Tseng et al (WO2007038686, published 04/05/2007).
Regarding claims 149-150, 155-156, 158-161, Tseng et al teach a composition comprising cross-linked high molecular weight hyaluronan, tumor necrosis factor-stimulated gene 6, pentraxin 3, and thrombospondin (Tseng et al, pg. 1-2, paragraphs 0006-0007). Additionally, Tseng et al teach in a further or alternative embodiment of the purified compositions, the cross-linking of the HA comprises a covalent bond to a heavy chain of inter-a-trypsin inhibitor (Tseng et al, pg. 2, paragraph 0007). Tseng et al further teach that the preparations may be used in the treatment of various cancers including prostate cancer, colorectal cancer, liver cancer, kidney cancer, bladder cancer, brain cancer, ovarian cancer, lung cancer, melanoma, breast cancer, thyroid cancer, pancreatic cancer, stomach cancer, lung cancer, leukemia, lymphoma, sarcomas, gastric cancer, bone cancer, oral cancer, eye cancer, or carcinoma (Tseng et al, pg. 39, paragraph 00260).
Regarding claim 158, it is noted that Tseng et al define treatment to include inhibition of cancer (Tseng et al pg. 9, paragraph 0065).
Regarding claim 159, it is noted that when treating cancer, it is typical in the art to kill cancer cells.
Regarding claims 151-154 and 163, the method of claim 149 is addressed above. Tseng et al further teach the composition comprising HC-HA/PTX3 wherein the components of the purified compositions are prepared from a human amniotic material selected from a human amniotic membrane, a human amniotic jelly, a human amniotic stroma, or a combination thereof (Tseng et al, pg. 2, paragraph 0007). Tseng et al further teach methods of preparation of the purified composition includes:
• Obtaining a frozen or previously-frozen human placenta;
• Thawing the placenta and isolating the human amniotic material from the thawed placenta; and
• homogenizing the human amniotic material in a suitable buffer.
In a further or alternative embodiment, the preparation procedure further includes:
• Freezing the human amniotic material; and
• Grinding the frozen amniotic material.
In a further or alternative embodiment, the preparation procedure further includes:
• Lyophilizing the homogenate; or
• Centrifuging the homogenate and isolating the supernatant from the centrifuged homogenate.
In a further or alternative embodiment, the preparation procedure further includes:
• Lyophilizing the supernatant into powder.
Regarding claim 151, it is noted that the composition comprising HC-HA/PTX3 isolated from amniotic or placental tissue would be native.
Regarding claim 152, it is noted that amnion is fetal tissue.
Therefore, Tseng et al meets the limitations of claims 151-154 and 163.
Regarding claims 155 and 156, the method of claim 149 is discussed above. Furthermore, Tseng et al teach that after lyophilizing the homogenate (comprising the HC-HA/PTX3 complex) to powder you can take the step of admixing the homogenate or the powder with a pharmaceutically acceptable carrier for a nonsolid dosage form or an extended-release solid dosage form (Tseng et al, pg. 2, paragraph 0015). It is noted that HC1 is inherent to the HC-HA/PTX3 complex where HA has a covalent bond to a heavy chain of inter-a-trypsin inhibitor as disclosed in Tseng et al (Tseng et al, pg. 2, paragraph 0007). Therefore, Tseng et al meets all of the limitations of claims 155 and 156.
Regarding claim 157, Tseng et al teach that the subject may be human (Tseng et al, pg. 9, paragraph 0064).
Regarding claims 162 and 164-165, the method of claim 149 is discussed above. Tseng et al further teach that for injections, AM preparations and purified compositions described herein may be formulated in aqueous solutions, in physiologically compatible buffers such as Hank's solution, Ringer's solution, physiological saline buffer, or other suitable solutions. For transmucosal administration, penetrants appropriate to the barrier to be permeated are used in the formulation. Such penetrants are generally known in the art. For other parenteral injections, appropriate formulations may include aqueous or nonaqueous solutions, preferably with physiologically compatible buffers or excipients. Such excipients are generally known in the art. (Tseng et al, pg. 25, paragraph 00191).
Regarding claim 162, it is noted that Tseng et al teach administration of the HC-HA/PTX3 by injection.
Regarding claims 164 and 165, it is noted that Tseng et al teach the formulations include compatible buffer or excipients.
Therefore, Tseng et al meets the limitations of claims 162 and 164-165.
Tseng et al meet all the limitations of claims 149-165. Therefore, all claims are rejected for the reasons of record above as being anticipated by Tseng et al.
Nonstatutory 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 149-165 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,040,821 in view of Tseng et al (WO2007038686, published 04/05/2007).
The instant claims and the conflicting claims both recite a HC-HA/PTX3 complex; however the conflicting claims do not recite the treatment of cancer using a HC-HA/PTX3 complex. This deficiency is remedied by Tseng et al.
The teachings of Tseng et al. are detailed above.
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the time of the invention to combine the conflicting claims with the teachings of Tseng et al. to develop a method of treating a cancer in an individual in need thereof, the method comprising administering a therapeutically effective amount of a HC-HA/PTX3 complex to the individual, thereby treating the cancer in the individual. One of ordinary skill in the art would have been motivated to do so, because the conflicting claims recite a HC-HA/PTX3 complex. Furthermore as indicated above, Tseng et al. teach that a HC-HA/PTX3 complex may be used to treat various forms of cancer. Therefore it would have been prima facie obvious to modify the conflicting claims to recite a method of using a HC-HA/PTX3 complex to treat cancer, because there would have been a reasonable expectation that the resultant invention would be effective in treating various forms of cancer. The invention of the conflicting claims and Tseng et al. meets all of the limitations of claims 155 and 156.
Regarding claim 157, Tseng et al teach that the subject may be human (Tseng et al, pg. 9, paragraph 0064).
Regarding claims 162, 164-165, the method of claim 149 is discussed above. Tseng et al further teach that for injections, AM preparations and purified compositions described herein may be formulated in aqueous solutions, in physiologically compatible buffers such as Hank's solution, Ringer's solution, physiological saline buffer, or other suitable solutions. For transmucosal administration, penetrants appropriate to the barrier to be permeated are used in the formulation. Such penetrants are generally known in the art. For other parenteral injections, appropriate formulations may include aqueous or nonaqueous solutions, preferably with physiologically compatible buffers or excipients. Such excipients are generally known in the art. (Tseng et al, pg. 25, paragraph 00191).
Regarding claim 162, it is noted that Tseng et al teach administration of the HC-HA/PTX3 by injection.
Regarding claims 164 and 165, it is noted that Tseng et al teach the formulations include compatible buffer or excipients.
Therefore the instant claims are prima facie obvious over the conflicting claims in view of Tseng et al.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.K.D./Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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