DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 8/06/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 8/06/2025, have been fully considered.
Applicant traverses the rejections of claims under 35 U.S.C. 103(a) as being unpatentable over Tseng et al (US 2015/0166624; of record), noting that “independent claims 1 and 34 have been amended to clarify the subject matter” (Applicant Arguments, Page 6). In particular, Applicant points out that claim 1 has been amended to require “inhibiting a tumor regrowth… comprising contacting an area surrounding the tumor” (Applicant Arguments, Page 6) and that claim 34 has been amended to require “contacting the tumor or an area surrounding the tumor… thereby killing the cancer cells of the tumor in the individual” (Applicant Arguments, Page 7). As argued by Applicant, “as recited in present claim 1, the contacting an area surround the tumor before or after surgery with HC-HA/PTX3 complex is not provided as a targeted tumor or cancer treatment per se” but “as a treatment that inhibits the regrowth and hinders regrowth of cancer cells. The inhibition of regrowth of a tumor inevitably restricts cell growth and hastens the death of the tumor” (Applicant Arguments, Page 8). And, as argued by Applicant, “[t]he method of claim 34 is directed at killing of cancer cells in an area surrounding a tumor before or after surgery” (Applicant Arguments, Page 8). As argued by Applicant, “Tseng is silent as to ‘a method of inhibiting regrowth of a tumor… comprising contacting an area surrounding a tumor…’” and is silent as to “’a method of killing cancer cells of a tumor…’” as recited by the amended claims (Applicant Arguments, Page 8).
The argument is not found persuasive. As discussed in the instant rejection (which has been modified to address the amended claims), Tseng et al teach “an HC-HA/PTX3 complex… administered for the treatment of cancer” (Paragraph 0627, Example 23) wherein “it is expected that treatment with HC-HA/PTX3 will inhibit or prevent cancers or their progress into late stage phenotypes” (Paragraph 0629). As further taught by Tseng et al, “[e]xemplary cancer types that are treated… include… breast cancer… [and] colon cancer” (Paragraph 0377). Additionally, Tseng et al teach an “HC-HA-PTX3 complex… administered for the treatment of a non-healing wound” (Paragraph 0631, Example 24) wherein “it is expected that treatment with HC-HA/PTX3 will promote the healing of the wound” (Paragraph 0633). As further taught by Tseng et al in the treatment of wounds, “[i]n some embodiments, a pharmaceutical composition comprising an nHC-HA/PTX3 or rcHC-HA/PTX3 complex… is applied to a surgical incision”, more specifically “to the site of a colon resection” or “the site of a breast surgery (e.g., … mastectomy)” (Paragraph 0383). Accordingly, it would have been prima facie obvious to contact an area surrounding a solid tumor (in particular, wherein the solid tumor is a breast cancer tumor or colon cancer tumor) prior to, during, and, especially, after a surgical procedure (in particular, wherein the surgical procedure is a colon resection or mastectomy for the removal of said tumor). It would have been obvious to do so to promote healing of the surgical incision caused by said surgical procedure as well as to inhibit the regrowth of said tumor with a reasonable expectation of success.
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.
Claim 65 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
As amended, claim 1 is drawn to “[a] method of inhibiting tumor regrowth… comprising contacting an area surrounding the tumor… with an isolated… HC-HA/PTX3 complex”.
Claim 65 is drawn to “[t]he method of claim 1, wherein the contacting is by injection of the isolated… HC-HA-PTX3 complex into the area surrounding the tumor, the surrounding tissue, or a combination thereof.”
Claim 65 is indefinite because it is unclear what how “the area surrounding the tumor” and “the surrounding tissue” differ from one another.
Furthermore, assuming arguendo that there is a difference between “the area surrounding the tumor” and “the surrounding tissue” as recited by claim 65, then claim 1 – which is limited to “contacting an area surrounding the tumor” does not provide antecedent basis for contacting “the surrounding tissue” as recited by claim 65.
As such, claim 65 is rejected as indefinite.
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.
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 1-7, 16-18, 30, 32-40, 49-51 and 66 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tseng et al (US 2015/0166624; of record).
As amended, claim 1 is drawn to a method of inhibiting a tumor regrowth (more specifically, wherein the tumor is a solid tumor (claim 6) and/or breast cancer or colon cancer (claim 7)) in an individual in need thereof, the method comprising contacting (more specifically, by injection (claim 65)) an area surrounding the tumor prior to, during, or after a surgical (more specifically a surgical excision (claim 2)) or non-surgical procedure with an isolated heavy chain-hyaluronan/pentraxin 3 (HC-HA/PTX3) complex (more specifically, wherein the HC-HA/PTX3 is a native HC-HA/PTX3 complex and/or a reconstituted HC-HA/PTX3 complex (claim 17)), thereby inhibiting regrowth of the tumor.
Tseng et al teach “an HC-HA/PTX3 complex… administered for the treatment of cancer” (Paragraph 0627, Example 23) wherein, “[i]n some examples, the HC-HA/PTX3 complex used… is an isolated native HC-HA/PTX3 complex (nHC-HA/PTX3)” and, “[i]n some examples, the HC-HA/PTX3 complex used… is a reconstituted HC-HA/PTX3 complex (rcHC-HA/PTX3)” (Paragraph 0630). In particular, Tseng et al teach that “[a]n HC-HA/PTX3 complex… is administered to a subject having a cancer, such as a solid tumor cancer… as a solution… for… injective… application” wherein “it is expected that treatment with HC-HA/PTX3 will inhibit or prevent cancers or their progress into late stage phenotypes” (Paragraph 0629). As further taught by Tseng et al, “[e]xemplary cancer types that are treated… include… breast cancer… [and] colon cancer” (Paragraph 0377).
Additionally, Tseng et al teach an “HC-HA-PTX3 complex… administered for the treatment of a non-healing wound” (Paragraph 0631, Example 24) wherein, “[i]n some examples, the HC-HA/PTX3 complex used… is an isolated native HC-HA/PTX3 complex (nHC-HA/PTX3)” and, “[i]n some examples, the HC-HA/PTX3 complex used… is a reconstituted HC-HA/PTX3 complex (rcHC-HA/PTX3)” (Paragraph 0634). In particular, Tseng et al teach that “[a]n HC-HA/PTX3 complex… is administered to a subject having a non-healing wound… as a solution, gel topically or subcutaneously for the treatment at the site of the wound” wherein “it is expected that treatment with HC-HA/PTX3 will promote the healing of the wound” (Paragraph 0633). As further taught by Tseng et al in the treatment of wounds, “[i]n some embodiments, a pharmaceutical composition comprising an nHC-HA/PTX3 or rcHC-HA/PTX3 complex… is applied to a surgical incision”, more specifically “to the site of a colon resection” or “the site of a breast surgery (e.g., … mastectomy)” (Paragraph 0383).
In view of the foregoing, it would have been prima facie obvious to contact by injection an area surrounding a solid tumor (in particular, wherein the solid tumor is a breast cancer tumor or colon cancer tumor) prior to, during, or after a surgical procedure (in particular, wherein the surgical procedure is a colon resection or mastectomy for the removal of said tumor). It would have been obvious to do so to promote healing of the surgical incision caused by said surgical procedure as well as to inhibit the regrowth of said tumor with a reasonable expectation of success.
As such, claims 1-2, 6-7 and 17 are rejected as prima facie obvious.
Claim 3 is drawn to the method claim 1, wherein the non-surgical procedure comprises chemotherapy, immunotherapy, or targeted therapy.
At the outset, claim 3 limits the non-surgical procedure of claim 1 without requiring said limitation.
Furthermore, Tseng et al teach that “[i]n some embodiments, [the] pharmaceutical composition further comprises… a chemotherapeutic agent” (Paragraph 0037), further disclosing “a combination comprising (a) an nHC-HA/PTX3 or rcHC-HA/PTX3 complex… and (b)… a chemotherapeutic agent” (Paragraph 0039).
As such, claim 3 is, in either case, rejected as prima facie obvious.
Claims 4-5 are drawn to the method of claim 1, wherein the area surrounding or within the tumor comprises a surgical margin (claim 4), a peritumor region (claim 5).
As discussed above, Tseng et al teach that “an nHC-HA/PTX3 or rcHC-HA/PTX3 complex… is applied to the site of a colon resection” or “the site of a breast surgery (e.g., … mastectomy)” (Paragraph 0383), which would entail contacting a surgical margin (i.e., “an area of apparently tissue around a tumor that has been surgically removed”, as defined by the instant Specification (Paragraph 0076)) as well as a peritumor region (i.e., “the area surrounding the tumor comprises a peritumor region”, as indicated by the instant Specification (Paragraph 0008)).
As such, claims 4-5 are also rejected as prima facie obvious.
Claim 16 is drawn to the method of claim 1, wherein the area surrounding or within the tumor is contacted with about 10 µg to 100 mg of the isolated HC-HA/PTX3 complex.
Tseng et al teach that “[a]n indicated daily dosage in… humans, is in the range from about 0.5 mg to about 100 mg” (Paragraph 0335).
As such, claim 16 is also rejected as prima facie obvious.
Claim 18 is drawn to the method of claim 17, wherein the native HC-HA/PTX3 complex is isolated from a fetal support tissue.
As discussed above, Tseng et al teach “[a]n HC-HA/PTX3 complex generated by methods described herein is administered to a subject having a cancer, such as a solid tumor cancer” (Paragraph 0629). And, as further taught by Tseng et al, “[i]n some examples, the nHC-HA/PTX3 is isolated from umbilical cord tissue” or “amniotic membrane” (Paragraph 0630).
As such, claim 18 is also rejected as prima facie obvious.
Claims 30 and 32-33 are drawn to the method of claim 1, wherein the method inhibits tumor regrowth by killing cancer cells (claim 30), inhibiting proliferation of cancer cells (claim 32) and/or inhibiting metabolic activity of cancer cells (claim 33).
At the outset, as noted by the court in Hoffer v. Microsoft Corp., 405 F.3d 1326 (Fed. Cir. 2005), a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003)). In the instant case, the wherein clauses (i.e., killing cancer cells, inhibiting proliferation of cancer cells and/or inhibiting metabolic activity of cancer cells) simply express the intended result of a process step positively recited (i.e., injecting an HC-HA/PTX3 complex into an area surrounding or within a tumor prior to, during, or after a surgical or non-surgical procedure).
As such, the wherein clauses are not afforded patentable weight and claims 30 and 32-33 are thus rejected as prima facie obvious for the same reasons as applied to claim 1.
Nevertheless, Tseng et al teach “a well-established link between inflammatory cells, macrophages in particular, and cancer” wherein “a chronic pro-inflammatory environment” and “[t]he chronic production of large quantities of inflammatory mediators… can lead to tumor cell proliferation and survival” and, “[t]hus, early tumor development is, in many instances, characterized by a polarized inflammatory M1-like macrophage environment” (Paragraph 0628), further stating that “because HC-HA/PTX3 can suppress M1 macrophage polarization, it is expected that treatment with HC-HA/PTX3 will inhibit or prevent cancers or their progress” (Paragraph 0629).
Based on the foregoing, it is evident that the administration of HC-HA/PTX3 to inhibit tumor regrowth in the treatment of cancer as taught by Tseng et al will result in the killing of cancer cells, the inhibiting of proliferation of cancer cells, and the inhibiting of metabolic activity of cancer cells.
As such, claims 30 and 32-33 are additionally rejected as prima facie obvious.
Claim 34 is drawn to a method of killing cancer cells of a tumor in an individual in need thereof, comprising contacting the tumor or an area surrounding or within the tumor prior to, during or after a non-surgical or surgical procedure with an isolated heavy chain-hyaluronan/pentraxin 3 (HC-HA/PTX3) complex, thereby killing the cancer cells of the tumor in the individual.
Although drafted independently, claim 34 and claims 35-40, 49-51 and 66 dependent therefrom overlap in scope with the method claim 1 as further limited by claim 30 and claims 2-7 and 16-18 dependent therefrom.
As such, claims 34, 35-40, 49-51 and 66 are also rejected as prima facie obvious for the same reasons as applied to claims 1-7, 16-18 and 30.
Conclusion
Any new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611