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 .
Status of the Application
Claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are pending in the application as of the preliminary amendment submitted 04/18/2024. Claims 2-6, 10-18, 25-34, 37-44 and 48-53 are cancelled. Claims 54-58 are newly added. Claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are examined herein.
Priority
This application is a 371 of PCT/IB2022/060007 filed 10/18/2022, which claims priority to PRO 63/257,099 filed 10/18/2021.
The subject matter of claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are supported by the ‘099 provisional application and accordingly, have an effective filing date of 10/18/2021.
Claim Interpretation
The recitation of the limitation “head or neck cancer” and alternatively “head and neck cancer” in the claims have been treated as referring to the same disease or condition. The instant specification uses the terms interchangeably and does not distinguish the two.
Duplicate Claims, Warning
Applicant is advised that should claim 56 be found allowable, claims 7 and 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, claim 7, claim 19 and claim 56 have identical claim scope, because even though claim 7 recites “wherein the human subject has been diagnosed with head or neck cancer”, claim 19 recites “wherein the human subject has been diagnosed as suffering from head or neck cancer”, claim 56 recites “wherein the human subject has head and neck cancer”, all three claims require a clinical diagnosis of the disease, and the addition of "suffering" (claim 19) does not change the covered class of subjects. Besides, “head or neck cancer” and “head and neck cancer” have been interpreted to refer to the same condition.
Therefore, claims 7, 19 and 56 are substantial duplicates of each other.
Claim Objections
Claims 35-36 is objected to because of the following informalities:
In claim 35, lines 1-4 should read “A method for treating a human subject, wherein the subject is 1) identified as suffering from mucositis and 2) identified as HPV positive, comprising administering to the human subject an effective amount of EC-18, thereby treating [[or preventing ]]the mucositis” for proper grammar and consistent claim language.
In claim 36, line 2 has a typographical error and should read “subject as suffering from mucositis and being [[BPV]]HPV positive”. Moreover, the “18” in EC-18 appearing at the end of claim 36 appears to have been inadvertently deleted by the claim amendment.
Appropriate correction is required.
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 23-24 and 47 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.
Regarding claim 23, the claim recites “pentoxifylline including with vitamin E; chlorhexidine gluconate (including oral rinse) … a super oxide dismutase mimetic such as super oxide dismutase mimetic M40403 …”. The recitation of the exemplary claim language “including” and “such as” and limitations in parentheses renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Therefore, the metes and bounds of claims 23 are indefinite.
For the purpose of applying prior art, claim 23 has been interpreted without the limitations following the term “including”, “such as” and the limitations in parenthesis appearing in the claim.
Regarding claim 24, the claim recites “pentoxifylline including with vitamin E”. The recitation of the exemplary claim language “including” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Therefore, the metes and bounds of claims 24 are indefinite.
For the purpose of applying prior art, claim 24 has been interpreted without the limitations following the term “including” appearing in the claim.
Regarding claim 47, the claim depends from itself and thus its boundaries cannot be ascertained by a person of ordinary skill in the art. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 47 has been interpreted to depend from 46.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 36, the claim depends from claim 35 and recites “further comprising 1) identifying the subject as suffering from mucositis and being HPV positive (see claim objection above) and 2) administering to the identified subject the EC-18 (see claim objection above)”. Claim 36 does not further limit the scope of claim 35 (wherein in both method claims the human subject is being identified as suffering from mucositis and HPV, followed by administering EC-18 to the subject), which is improper.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 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, 8-9, 20-23, 35-36 and 54-55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sohn (US 2017/0128404 A1, 11 May 2017, hereinafter Sohn ‘404).
Regarding instant claim 1, Sohn ‘404 teaches a method for treating mucositis comprising administering an effective amount of a compound of formula 1, particularly PLAG, to a patient in need thereof (Para. [0013]; Para. [0021]; Claim 31). Sohn ‘404 teaches PLAG as a compound of Formula 2, i.e., 1-palmitoyl-2-linoleoyl-3-acetylglycerol (Paras. [0017]-[0018]).
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Sohn ‘404 teaches the compositions being administered to humans (Para. [0029]; Para. [0063]; Para. [0075]). Sohn ‘404 teaches the effective amount is sufficient to achieve a desired result in a medical treatment (Para. [0026]). Sohn ‘404 teaches the term “treatment” to include prophylaxis, mitigation, amelioration, delay or reduction of symptoms, as well as partial or complete elimination or prevention of symptoms, of mucositis by administering the composition of the invention (Para. [0027]). Sohn ‘404 teaches in vivo effect of PLAG on oral ulceration, wherein the human subjects showed improvement in ulcer frequency and ulcer severity (pain and size) (Paras. [0081]-[0082], TABLE 1).
The instant specification in page 2, eighth to ninth paragraphs, evidences “PLAG” to be “EC-18” of the instant claims.
Therefore, Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1.
Regarding instant claims 8-9 and 55, Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1. Sohn ‘404 teaches mucositis may occur as an adverse effect of cancer treatment comprising chemotherapy and/or radiotherapy (Para. [0021]; Para. [0049]; Para. [0053]; Claim 41; Claim 42). Sohn ‘404 teaches wherein the mucositis is caused by a drug, wherein the drug is cisplatin (Para. [0052]; Claim 43). Therefore, Sohn ‘404 anticipates the limitations of instant claims 8-9 and 55.
Regarding instant claim 20, Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1. Sohn ‘404 teaches that the administration of PLAG to the patients significantly improves the symptoms of oral ulceration (Para. [0020]; Paras. [0081]-[0082], TABLE 1). Therefore, Sohn ‘404 anticipates the limitations of instant claim 20.
Regarding instant claims 21 and 54, Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1. Sohn ‘404 teaches wherein the mucositis is oral mucositis, more specifically, oral ulceration (Para. [0020]; Para. [0081]; Claim 34; Claim 35). Therefore, Sohn ‘404 anticipates the limitations of instant claims 21 and 54.
Regarding instant claims 22-23, Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1. Sohn ‘404 teaches the monoacetyldiacylglycerol compound may be administered alone or in combination with an additional agent or therapy treating or alleviating mucositis sequentially or simultaneously (i.e., co-administered), with Palifermin listed as an example (Para. [0024]; Claim 46; Claim 47). Therefore, Sohn ‘404 anticipates the limitations of instant claims 22-23.
Regarding instant claims 35-36 (see 35 U.S.C. 112(d) rejection above, claim 36 is not further limiting), Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1. Sohn ‘404 teaches wherein the mucositis is caused by an infection such as herpes simplex virus (HSV) (Para. [0021]; Para. [0048]; Claim 39; Claim 40). The disclosure of Sohn ‘404 teaches embodiments wherein the compound of Formula 2 (i.e., EC-18 or PLAG) is administered to a subject in need thereof to achieve treatment of mucositis, wherein the mucositis can be caused by HPV infection. This implicitly means the subject has been identified as having mucositis wherein the mucositis can be caused by HPV infection, thereby anticipating the limitations of instant claims 35-36.
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 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Sohn (US 2017/0128404 A1, 11 May 2017, hereinafter Sohn ‘404) as applied to claims 1, 8-9, 20-23, 35-36 and 54-55 above.
The teachings of Sohn ‘404 are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claims 46-47, Sohn ‘404 anticipates the method for treating a human subject having mucositis and identified as being HPV positive, as in instant claim 35. Sohn ‘404 teaches an embodiment wherein in the method of treating a subject for mucositis, the mucositis may occur as an adverse effect of cancer treatment comprising chemotherapy and/or radiotherapy and the subject is being treated with cisplatin (Para. [0021]; Para. [0049]; Para. [0053]; Claim 42; Claim 43). Sohn ‘404 teaches several forms of mucosal damage such as those related to herpes simplex virus (HSV) and candida infections can also appear as mucositis (Para. [0021]).
Although Sohn ‘404 does not explicitly teach the subject being treated for mucositis with the administration of PLAG (i.e., EC-18), wherein the mucositis is caused by a HPV infection (i.e., the subject is identified as being HPV positive) was also receiving treatment for cancer, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Sohn ‘404, to have applied the method of Sohn ‘404 to the treatment of such a patient population with a reasonable expectation of success. Sohn ‘404 teaches a method for treating mucositis comprising administering an effective amount of PLAG (i.e., EC-18), to a patient in need thereof. Sohn ‘404 teaches the mucositis is caused by HPV infection. Sohn ‘404 teaches mucositis usually occurs as an adverse effect of treatment of diseases such as cancer, wherein the mucositis may be caused by treatment with cisplatin.
Therefore, one of ordinary skill in the art would have been motivated to treat a subpopulation of subjects having mucositis caused by HPV infection afflicted with cancer and receiving a treatment with cisplatin, with the method of Sohn ‘404, to arrive at the method of the instant claims. The motivation being to extend the method of Sohn ‘404 to treating mucositis in different subpopulation of subjects.
Claims 7, 19, 45 and 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Sohn (US 2017/0128404 A1, 11 May 2017, hereinafter Sohn ‘404) as applied to claims 1, 8-9, 20-23, 35-36 and 54-55 above, in view of Anderson et al. (Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer, 16 October 2019, hereinafter Anderson) and Maxwell et al. (HPV-Associated Head and Neck Cancer: Unique Features of Epidemiology and Clinical Management, 26 August 2015, hereinafter Maxwell).
The teachings of Sohn ‘404 are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claims 7, 19, 56-58 and 45, Sohn ‘404 anticipates the method for treating a human subject having mucositis as in instant claim 1 (claims 7, 19 and 56-58) and instant claim 35 (claim 45). Sohn ‘404 mentions in the background section that radiotherapy to the head and neck can also cause oral mucositis (Para. [0003]).
Sohn ‘404 does not explicitly teach in the methods wherein the human subject has been diagnosed or has head and neck cancer.
Anderson teaches 70% of patients with head and neck cancer (HNC) receiving concurrent cisplatin and radiation experience severe oral mucositis (SOM), defined as grade 3 to 4 by the WHO scale (Pg. 3256, first column, last paragraph). Anderson teaches there are currently no approved drugs to reduce SOM duration, incidence, or severity for patients with solid tumors and that SOM management constitutes an unmet clinical need (Pg. 3256, second column, first paragraph).
Maxwell teaches human papillomavirus (HPV) is a recently identified causative agent for a subset of head and neck cancers, primarily in the oropharynx, and is largely responsible for the rising worldwide incidence of oropharyngeal cancer (OPC) (Abstract). Maxwell teaches patients with HPV-positive OPC have distinct risk factor profiles and generally have a better prognosis than patients with traditional, HPV-negative, head and neck cancer (Abstract; Pg. 93, last paragraph). Maxwell teaches identifying those patients with HPV-positive cancer who are at risk for recurrence and poor survival is critical in order to tailor individual treatment regimens and avoid potential undertreatment (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Sohn ‘404, Anderson and Maxwell, to have applied the method for the treatment of mucositis in a subject in need thereof as taught by Sohn ‘404, to a subset of patients who have head and neck cancer, are HPV positive and are undergoing treatment with cisplatin, to arrive at the method of the instant claims with a reasonable expectation of success. The motivation being to tailor the treatment regimen to address an unmet clinical need in the treatment of mucositis associated with head and neck cancers, thereby improving clinical outcomes (Anderson, Pg. 3256, second column, first paragraph).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Sohn (US 2017/0128404 A1, 11 May 2017, hereinafter Sohn ‘404) as applied to claims 1, 8-9, 20-23, 35-36 and 54-55 above, in view of Sohn et al. (WO 2019/106632 A1, 06 June 2019, hereinafter Sohn ‘632).
The teachings of Sohn ‘404 are set forth in the anticipation rejection above and incorporated herein by reference. Sohn ‘404 teaches a pharmaceutical composition for preventing, treating or improving mucositis, which comprises an effective amount of monoacetyldiacylglycerol of formula 1, especially PLAG (i.e., EC-18) (Para. [0025]; Paras. [0039]-[0041]; Para. [0077]; Claim 32). Sohn ‘404 teaches the method further comprises administering to a patient in need thereof an effective amount of an additional agent sequentially or simultaneously, wherein the additional agent is selected to be palifermin (Claim 46; Claim 47). Sohn ‘404 does not explicitly teach a kit.
Sohn ‘632 teaches a pharmaceutical composition for preventing or treating acute radiation syndrome comprising PLAG (i.e., EC-18) (Pg. 18, last paragraph - Pg. 19, continued paragraph). Sohn ‘632 teaches the pharmaceutical composition improved mucositis in subjects with severe acute radiation syndrome having oral mucositis (FIGS. 4 and 5). Sohn ‘632 teaches a kit comprising a) l-palmitoyl-2-linoleoyl-3-acetylglycerol (PLAG) (i.e., EC-18); (b) instructions for using the PLAG for treating or preventing acute radiation syndrome (ARS) of a subject (Pg. 21, first full paragraph - second full paragraph; Claim 33).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Sohn ‘404 and Sohn ‘632 to have devised a kit comprising EC-18 along with an additional therapeutic agent, say, palifermin and instructions, to arrive at a kit of the instant claims. The motivation being to provide ready-to-use compositions of EC-18 for easy access, thereby improving patient compliance (Sohn ‘632, Pg. 21, first full paragraph - second full paragraph).
Furthermore, in regards to instant claim 24 reciting instructions for using EC-18 to treat mucositis in a human subject, the instructions are non-functional descriptive material. Patentable weight need not be given to printed matter absent a new and unobvious functional relationship between the printed matter and the active agent. Lowry, 32 F.3d at 1583-84, 32 USPQ2d at 1035; In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). See MPEP 2111.05. In the instant case, the claimed instructions do not provide a new and nonobvious functional relationship between the printed matter and the active agent, EC-18, and thus are not given patentable weight.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16-17 of U.S. Patent No. 9,808,438 B2 in view of Anderson et al. (Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer, 16 October 2019, hereinafter Anderson) and Maxwell et al. (HPV-Associated Head and Neck Cancer: Unique Features of Epidemiology and Clinical Management, 26 August 2015, hereinafter Maxwell) and Sohn et al. (WO 2019/106632 A1, 06 June 2019, hereinafter Sohn ‘632).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method for treating mucositis in a subject in need thereof, comprising administering an effective amount of EC-18.
The instant claims are drawn to a method for treating a human subject having mucositis, comprising administering to the human subject an effective amount of EC-18, thereby treating the mucositis.
The claims of the reference ‘438 patent are drawn to a method for treating mucositis, comprising administering to a patient having mucositis a pharmaceutically effective amount of a compound of Formula 2 (i.e., PLAG or EC-18).
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Claim 1 of the reference ‘438 patent anticipates and/or renders obvious the method of instant claim 1 since the broader recitation of “patients” generally anticipates or renders obvious a narrower claim specifying the subject is human. Claims 4-7 of the reference ‘438 patent anticipates the limitations of instant claims 20-21 and 54-55. Claims 12-13 of the reference ‘438 patent anticipates the limitations of instant claims 8-9. Claims 16-17 of the reference ‘438 patent anticipates the limitations of instant claims 22-23. Claims 9-10 of the reference ‘438 patent anticipates the limitations of instant claims 35-36.
The claims of the reference ‘438 patent do not explicitly teach wherein the human subject being treated for mucositis and identified as being HPV positive, is also undergoing treatment for cancer (instant claims 46-47); wherein the human subject has been diagnosed with head and neck cancer (instant claims 7, 19, 45, 56-58); a kit comprising EC-18 according to instant claim 24.
Anderson teaches 70% of patients with head and neck cancer (HNC) receiving concurrent cisplatin and radiation experience severe oral mucositis (SOM), defined as grade 3 to 4 by the WHO scale (Pg. 3256, first column, last paragraph). Anderson teaches there are currently no approved drugs to reduce SOM duration, incidence, or severity for patients with solid tumors and that SOM management constitutes an unmet clinical need (Pg. 3256, second column, first paragraph).
Maxwell teaches human papillomavirus (HPV) is a recently identified causative agent for a subset of head and neck cancers, primarily in the oropharynx, and is largely responsible for the rising worldwide incidence of oropharyngeal cancer (OPC) (Abstract). Maxwell teaches patients with HPV-positive OPC have distinct risk factor profiles and generally have a better prognosis than patients with traditional, HPV-negative, head and neck cancer (Abstract; Pg. 93, last paragraph). Maxwell teaches identifying those patients with HPV-positive cancer who are at risk for recurrence and poor survival is critical in order to tailor individual treatment regimens and avoid potential undertreatment (Abstract).
Sohn ‘632 teaches a pharmaceutical composition for preventing or treating acute radiation syndrome comprising PLAG (i.e., EC-18) (Pg. 18, last paragraph - Pg. 19, continued paragraph). Sohn ‘632 teaches the pharmaceutical composition improved mucositis in subjects with severe acute radiation syndrome having oral mucositis (FIGS. 4 and 5). Sohn ‘632 teaches a kit comprising a) 1-palmitoyl-2-linoleoyl-3-acetylglycerol (PLAG) (i.e., EC-18); (b) instructions for using the PLAG for treating or preventing acute radiation syndrome (ARS) of a subject (Pg. 21, first full paragraph - second full paragraph; Claim 33).
Therefore, using similar rationale as applied in the 103 rejections above, one of ordinary skill in the art would have been motivated to treat a subpopulation of patients wherein the human subject being treated for mucositis and identified as being HPV positive, is also undergoing treatment for cancer; wherein the human subject has been diagnosed with head and neck cancer; and one of ordinary skill in the art would have been motivated to devise a kit comprising EC-18 to arrive at the instant claims with a reasonable expectation of success.
Therefore, claims 1-14 and 16-17 of the reference ‘438 patent in view of Anderson, Maxwell and Sohn ‘632 render instant claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58, either anticipated or prima facie obvious.
Thus, claims 1-14 and 16-17 of U.S. Patent No. 9,808,438 B2 and instant claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 12 of U.S. Patent No. 11,590,096 B2 in view of Sohn et al. (WO 2019/106632 A1, 06 June 2019, hereinafter Sohn ‘632), Sohn (US 2017/0128404 A1, 11 May 2017, hereinafter Sohn ‘404), Anderson et al. (Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer, 16 October 2019, hereinafter Anderson) and Maxwell et al. (HPV-Associated Head and Neck Cancer: Unique Features of Epidemiology and Clinical Management, 26 August 2015, hereinafter Maxwell).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method for treating a condition in a subject exposed to radiation, comprising administering an effective amount of EC-18.
The instant claims are drawn to a method for treating a human subject having mucositis, comprising administering to the human subject an effective amount of EC-18, thereby treating the mucositis.
The claims of the reference ‘096 patent are drawn to a for treating or preventing acute radiation syndrome in a human subject, comprising: identifying a human subject suffering from or susceptible to acute radiation syndrome; and administering to the identified human subject in need thereof a therapeutically effective amount of PLAG.
The claims of the reference ‘096 patent do not teach treating mucositis in a human subject or the limitations of instant dependent claims 7-9, 19-24, 35-36, 45-47 and 54-58.
Sohn ‘632 teaches PLAG (i.e., EC-18) can alleviate, prevent and/or treat the reduction of immune cells such as leukocytes, neutrophils and lymphocytes by radiation exposure, and alleviate inflammatory diseases like oral mucositis, and further increase the survival rate of subjects exposed to radiation (Pg. 2, fourth full paragraph). Sohn ‘632 teaches the pharmaceutical composition comprising PLAG (i.e., EC-18) improved mucositis in subjects with severe acute radiation syndrome having oral mucositis (FIGS. 4 and 5). Sohn ‘632 teaches a kit comprising a) 1-palmitoyl-2-linoleoyl-3-acetylglycerol (PLAG) (i.e., EC-18); (b) instructions for using the PLAG for treating or preventing acute radiation syndrome (ARS) of a subject (Pg. 21, first full paragraph - second full paragraph; Claim 33).
Sohn ‘404 teaches a method for treating mucositis comprising administering an effective amount of a compound of formula 1, particularly PLAG, to a patient in need thereof (Para. [0013]; Para. [0021]; Claim 31). Sohn ‘404 teaches PLAG as a compound of Formula 2, i.e., 1-palmitoyl-2-linoleoyl-3-acetylglycerol (Paras. [0017]-[0018]).
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Sohn ‘404 teaches the compositions being administered to humans (Para. [0029]; Para. [0063]; Para. [0075]). Sohn ‘404 teaches mucositis may occur as an adverse effect of cancer treatment comprising chemotherapy and/or radiotherapy (Para. [0021]; Para. [0049]; Para. [0053]; Claim 41; Claim 42). Sohn ‘404 teaches wherein the mucositis is caused by a drug, wherein the drug is cisplatin (Para. [0052]; Claim 43). Sohn ‘404 teaches wherein the mucositis is oral mucositis, more specifically, oral ulceration (Para. [0020]; Para. [0081]; Claim 34; Claim 35). Sohn ‘404 teaches the monoacetyldiacylglycerol compound may be administered alone or in combination with an additional agent or therapy treating or alleviating mucositis sequentially or simultaneously, with Palifermin listed as an example (Para. [0024]; Claim 46; Claim 47). Sohn ‘404 teaches wherein the mucositis is caused by an infection such as herpes simplex virus (HSV) (Para. [0021]; Para. [0048]; Claim 39; Claim 40). The disclosure of Sohn ‘404 teaches embodiments wherein the compound of Formula 2 (i.e., EC-18 or PLAG) is administered to a subject in need thereof to achieve treatment of mucositis, wherein the mucositis can be caused by HPV infection.
Anderson teaches 70% of patients with head and neck cancer (HNC) receiving concurrent cisplatin and radiation experience severe oral mucositis (SOM), defined as grade 3 to 4 by the WHO scale (Pg. 3256, first column, last paragraph). Anderson teaches there are currently no approved drugs to reduce SOM duration, incidence, or severity for patients with solid tumors and that SOM management constitutes an unmet clinical need (Pg. 3256, second column, first paragraph).
Maxwell teaches human papillomavirus (HPV) is a recently identified causative agent for a subset of head and neck cancers, primarily in the oropharynx, and is largely responsible for the rising worldwide incidence of oropharyngeal cancer (OPC) (Abstract). Maxwell teaches patients with HPV-positive OPC have distinct risk factor profiles and generally have a better prognosis than patients with traditional, HPV-negative, head and neck cancer (Abstract; Pg. 93, last paragraph). Maxwell teaches identifying those patients with HPV-positive cancer who are at risk for recurrence and poor survival is critical in order to tailor individual treatment regimens and avoid potential undertreatment (Abstract).
Summing up, Sohn ‘632 provides motivation to use EC-18 in the treatment of mucositis is subjects exposed to radiation treatments. Sohn ‘632 teaches a kit comprising EC-18. Sohn ‘404 teaches the subpopulation of patients as in instant claims 8-9, 20-21, 35-36, 46-47 and 54-55. Anderson and Maxwell provide motivation to extend the method to treating a subpopulation of subjects wherein the subject is having head and neck cancer and/or is HPV positive and undergoing treatment with cisplatin as in instant claims 7, 19, 45 and 56-58.
Therefore, using similar rationale as applied in the 103 rejections above, one of ordinary skill in the art would have been motivated to repurpose the use of EC-18 to the treatment of mucositis in a subject, to arrive at the method of the instant claims. A person of ordinary skill in the art would be motivated to treat a subpopulation of patients wherein the human subject being treated for mucositis and identified as being HPV positive, is also undergoing treatment for cancer; wherein the human subject has been diagnosed with head and neck cancer, to arrive at the method of the instant claims. A person of ordinary skill in the art would have been motivated to devise a kit comprising EC-18 to arrive at the kit of the instant claims with a reasonable expectation of success.
Therefore, claims 1, 6 and 12 of the reference ‘096 patent in view of Sohn ‘632, Sohn ‘404, Anderson and Maxwell render instant claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58, prima facie obvious.
Thus, claims 1, 6 and 12 of U.S. Patent No. 11,590,096 B2 and instant claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 14 of U.S. Patent No. 12,076,307 B2 in view of Sohn et al. (WO 2019/106632 A1, 06 June 2019, hereinafter Sohn ‘632), Sohn (US 2017/0128404 A1, 11 May 2017, hereinafter Sohn ‘404), Anderson et al. (Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer, 16 October 2019, hereinafter Anderson) and Maxwell et al. (HPV-Associated Head and Neck Cancer: Unique Features of Epidemiology and Clinical Management, 26 August 2015, hereinafter Maxwell).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method for treating a condition in a subject exposed to radiation, comprising administering an effective amount of EC-18.
The instant claims are drawn to a method for treating a human subject having mucositis, comprising administering to the human subject an effective amount of EC-18, thereby treating the mucositis.
The claims of the reference ‘307 patent are drawn to a for treating acute radiation syndrome in a subject, comprising: administering to the subject a therapeutically effective amount of 1-palmitoyl-2-linoleoyl-3-acetylglycerol (PLAG).
The claims of the reference ‘307 patent do not teach treating mucositis in a human subject or the limitations of instant dependent claims 7-9, 19-24, 35-36, 45-47 and 54-58.
Sohn ‘632 teaches PLAG (i.e., EC-18) can alleviate, prevent and/or treat the reduction of immune cells such as leukocytes, neutrophils and lymphocytes by radiation exposure, and alleviate inflammatory diseases like oral mucositis, and further increase the survival rate of subjects exposed to radiation (Pg. 2, fourth full paragraph). Sohn ‘632 teaches the pharmaceutical composition comprising PLAG (i.e., EC-18) improved mucositis in subjects with severe acute radiation syndrome having oral mucositis (FIGS. 4 and 5). Sohn ‘632 teaches a kit comprising a) 1-palmitoyl-2-linoleoyl-3-acetylglycerol (PLAG) (i.e., EC-18); (b) instructions for using the PLAG for treating or preventing acute radiation syndrome (ARS) of a subject (Pg. 21, first full paragraph - second full paragraph; Claim 33).
Sohn ‘404 teaches a method for treating mucositis comprising administering an effective amount of a compound of formula 1, particularly PLAG, to a patient in need thereof (Para. [0013]; Para. [0021]; Claim 31). Sohn ‘404 teaches PLAG as a compound of Formula 2, i.e., 1-palmitoyl-2-linoleoyl-3-acetylglycerol (Paras. [0017]-[0018]).
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Sohn ‘404 teaches the compositions being administered to humans (Para. [0029]; Para. [0063]; Para. [0075]). Sohn ‘404 teaches mucositis may occur as an adverse effect of cancer treatment comprising chemotherapy and/or radiotherapy (Para. [0021]; Para. [0049]; Para. [0053]; Claim 41; Claim 42). Sohn ‘404 teaches wherein the mucositis is caused by a drug, wherein the drug is cisplatin (Para. [0052]; Claim 43). Sohn ‘404 teaches wherein the mucositis is oral mucositis, more specifically, oral ulceration (Para. [0020]; Para. [0081]; Claim 34; Claim 35). Sohn ‘404 teaches the monoacetyldiacylglycerol compound may be administered alone or in combination with an additional agent or therapy treating or alleviating mucositis sequentially or simultaneously, with Palifermin listed as an example (Para. [0024]; Claim 46; Claim 47). Sohn ‘404 teaches wherein the mucositis is caused by an infection such as herpes simplex virus (HSV) (Para. [0021]; Para. [0048]; Claim 39; Claim 40). The disclosure of Sohn ‘404 teaches embodiments wherein the compound of Formula 2 (i.e., EC-18 or PLAG) is administered to a subject in need thereof to achieve treatment of mucositis, wherein the mucositis can be caused by HPV infection.
Anderson teaches 70% of patients with head and neck cancer (HNC) receiving concurrent cisplatin and radiation experience severe oral mucositis (SOM), defined as grade 3 to 4 by the WHO scale (Pg. 3256, first column, last paragraph). Anderson teaches there are currently no approved drugs to reduce SOM duration, incidence, or severity for patients with solid tumors and that SOM management constitutes an unmet clinical need (Pg. 3256, second column, first paragraph).
Maxwell teaches human papillomavirus (HPV) is a recently identified causative agent for a subset of head and neck cancers, primarily in the oropharynx, and is largely responsible for the rising worldwide incidence of oropharyngeal cancer (OPC) (Abstract). Maxwell teaches patients with HPV-positive OPC have distinct risk factor profiles and generally have a better prognosis than patients with traditional, HPV-negative, head and neck cancer (Abstract; Pg. 93, last paragraph). Maxwell teaches identifying those patients with HPV-positive cancer who are at risk for recurrence and poor survival is critical in order to tailor individual treatment regimens and avoid potential undertreatment (Abstract).
Summing up, Sohn ‘632 provides motivation to use EC-18 in the treatment of mucositis is subjects exposed to radiation treatments. Sohn ‘632 teaches a kit comprising EC-18. Sohn ‘404 teaches the subpopulation of patients as in instant claims 8-9, 20-21, 35-36, 46-47 and 54-55. Anderson and Maxwell provide motivation to extend the method to treating a subpopulation of subjects wherein the subject is having head and neck cancer and/or is HPV positive and undergoing treatment with cisplatin as in instant claims 7, 19, 45 and 56-58.
Therefore, using similar rationale as applied in the 103 rejections above, one of ordinary skill in the art would have been motivated to repurpose the use of EC-18 to the treatment of mucositis in a subject, to arrive at the method of the instant claims. A person of ordinary skill in the art would be motivated to treat a subpopulation of patients wherein the human subject being treated for mucositis and identified as being HPV positive, is also undergoing treatment for cancer; wherein the human subject has been diagnosed with head and neck cancer, to arrive at the method of the instant claims. A person of ordinary skill in the art would have been motivated to devise a kit comprising EC-18 to arrive at the kit of the instant claims with a reasonable expectation of success.
Therefore, claims 1, 9 and 14 of the reference ‘307 patent in view of Sohn ‘632, Sohn ‘404, Anderson and Maxwell render instant claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58, prima facie obvious.
Thus, claims 1, 9 and 14 of U.S. Patent No. 12,076,307 B2 and instant claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are not patentably distinct.
This is a nonstatutory double patenting rejection.
Conclusion
Claims 1, 7-9, 19-24, 35-36, 45-47 and 54-58 are rejected.
Claims 35-36 is objected to.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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