The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-4, 6, 8-11 and 13-21 are presented for examination.
Acknowledgement is made of Applicant’s electronic Petition to Make Special Based on Age under 37 C.F.R. §1.102(c)(1), filed May 30, 2025, which was granted on June 10, 2025.
Acknowledgment is made of the present application as a divisional of U.S. Patent Application No. 18/537,765, filed December 12, 2023, now U.S. Patent No. 12,350,264 B2, which is a continuation-in-part of U.S. Patent Application No. 17/778,369, filed May 19, 2022, which is a National Stage (371) entry of PCT Application No. PCT/US2020/061842, filed November 23, 2020, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Nos. 62/939,564, filed November 22, 2019, 63/077,888, filed September 14, 2020, and 63/387,188, filed December 13, 2022.
Requirement for Restriction/Election
Applicant’s election without traverse of the invention of Group I (original claims 1-13), directed to a method for treating an age-associated inflammation in a patient in need thereof comprising administering a therapeutically effective amount of a long interspersed nuclear element-1 (L1) endonuclease (EN) inhibitor to the patient from those recited therein, and the election of the L1 EN inhibitor AD34 as the single disclosed species of inhibitor to be administered, to which examination on the merits will be confined, as stated in the reply filed October 24, 2025, is acknowledged by the Examiner.
The claim listing filed with the response dated October 24, 2025 seeks amendment to the claims to now specify the treatment of “a cancer-associated inflammation” from “an age-associated inflammation” (claim 1), thereby obviating the required election of a single disclosed species of “age-associated inflammation” previously set forth at p.4-5 of the Requirement for Restriction/Election dated July 25, 2025.
In the reply filed October 24, 2025, Applicant provides a provisional preemptive election of “cancer” as the single disclosed species of “cancer-associated inflammation”, which reads on claims 2, 6, 8 and 10.
Applicant also seeks the addition of new claims 16-21, which further define the method of original Group I and, thus, are included with those claims presently under examination insofar as they read on the species elected for examination.
In the Table at p.68 of the as-filed specification, Applicant identifies the structure of AD34 as
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Therefore, for the reasons above and those made of record at p.2-9 of the Office Action dated July 25, 2025, the requirement remains proper and is hereby made FINAL.
Claims 14-15 are withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to non-elected subject matter.
The claims that are drawn to the elected invention and elected species are claims 1-4, 6, 8-11, 13, and 16-21 and such claims are herein acted on the merits infra.
Applicant’s elected species of AD34 appears to be free of prior art that would be applicable with regard to the effective filing date of the claims under AIA 35 U.S.C. §102 and/or 35 U.S.C. §103. As such, the search has been expanded to include another species within the genus of L1 EN inhibitors encompassed by claims 1 and 10. As the Examiner has located prior art pertaining to the species of AD37 (also known as tranexamic acid), Applicant’s attention is directed below to the rejection under AIA 35 U.S.C. §102(a)(1).
The Examiner takes no position on the patentability of any other inhibitor within Applicant’s claims aside from AD34 (the originally elected species), or the expanded species of AD37 (tranexamic acid) set forth above.
Priority
Acknowledgment is made of the present application as a divisional of U.S. Patent Application No. 18/537,765, filed December 12, 2023, which is a continuation-in-part of U.S. Patent Application No. 17/778,369, filed May 19, 2022, which is a National Stage (371) entry of PCT Application No. PCT/US2020/061842, filed November 23, 2020, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Nos. 62/939,564, filed November 22, 2019, 63/077,888, filed September 14, 2020, and 63/387,188, filed December 13, 2022. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d. 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of prior-filed U.S. Provisional Patent Application Nos. 62/939,564, filed November 22, 2019, or 63/077,888, filed September 14, 2020, fail to provide adequate written support and/or enabling guidance in the manner set forth under 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 for one or more claims presently under examination. Specifically, the limited disclosure of the ‘564 or ‘888 applications fail to describe any one or more of the instantly claimed L1 EN inhibitors, let alone any use thereof, that would support Applicant’s broadly claimed methods of body treatment defined by independent claims 1, 4 and 10, as well as the specific dependent embodiments thereon. As such, the instant claims are not entitled to the benefit of the earlier effective filing dates of the ‘564 or ‘888 applications.
The disclosure of prior-filed U.S. Provisional Patent Application No. 63/387,188, filed December 13, 2022, fails to provide adequate written support and/or enabling guidance in the manner set forth under 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 for one or more of the claims presently under examination. Specifically, the ‘188 application discloses the specific compounds of AD34 and AD36-AD55 instantly claimed, but fails to provide any clear evidentiary support that such compounds actually function as L1 EN inhibitors (see Table 3, p.50-59 of the ‘188 disclosure, which indicates that compounds AD37 through AD55 were “not yet tested” by the “N.D.” (no data) designations). As a result, Applicant has failed to provide sufficient written support and enabling guidance relevant to establishing the function of the full scope of L1 EN inhibitors instantly claimed so as to be correlated to the recited uses of the instant claims in affecting cancer-associated inflammation via L1 EN inhibition. As a result, Applicant is also not entitled to the benefit of the earlier effective filing date of the ‘188 provisional application.
The disclosure of prior-filed U.S. Patent Application No. 17/778,369, filed May 19, 2022, or PCT Application No. PCT/US2020/061842, filed November 23, 2020 (of which the ‘369 application is a National Stage entry thereof) fails to provide adequate written support and/or enabling guidance in the manner set forth under 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 for one or more claims presently under examination. Specifically, the ‘369 or ‘842 disclosures are silent as to any one or more of the L1 EN inhibitors (AD34, AD36-AD55) instantly claimed, let alone any use thereof (e.g., for treating cancer-associated inflammation, as claimed). As a result, Applicant is not entitled to the benefit of the earlier effective filing date of either one of the ‘369 or ‘842 applications.
The disclosure of U.S. Patent Application No. 18/537,765, filed December 12, 2023, also fails to provide adequate written support and/or enabling guidance in the manner set forth under 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 with regard to the subject matter of claims 1-4, 9 and 16 for the same reasons discussed below in the rejection of such claims under 35 U.S.C. §112(a) (pre-AIA first paragraph) for the addition of new matter under the written description requirement. As set forth below, the prior-filed ‘765 application fails to provide adequate written support for the subject matter of claims 1-4, 9 and 16 pertaining to the treatment of “cancer-associated inflammation” in a subject that does not actually have cancer. As such, Applicant’s claims 1-4, 9 and 16 are not entitled to the benefit of the earlier effective filing dates of the ‘765 application.
Accordingly, the effective filing date of claims 1-4, 9 and 16 is May 30, 2025 (the filing date of the instant application) and the effective filing date of claims 6, 8, 10-11, 13, and 17-21 is December 12, 2023 (the filing date of the ‘765 application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Listing of References in the Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP §609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the Examiner on form PTO-892 or by Applicant in the attached and initialed information disclosure statement, they have not been considered.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed May 30, 2025 (five pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08A, the Examiner has considered the cited references.
Objections to the Claims
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 2 is objected to for failing to recite proper Markush construction to define the “disease or disorder” (“selected from the group consisting of: vision loss, hearing loss, peripheral degenerative diseases, or cardiovascular dysfunction, skin aging, chemotherapy-induced adverse effects, hematopoietic stem cell function, physical function, and cancer”).
Proper Markush construction requires the language “selected from the group consisting of A, B, and C” (not “selected from the group consisting of A, B, or C, and D” as recited). See MPEP §2173.05(h)(I) for clarification of Markush limitations.
Appropriate correction is required.
Claims 9 and 13 are objected to for reciting “further comprising an administering”, which is grammatically awkward.
Appropriate correction is required.
Applicant may wish to consider amending such claims to recite ---further comprising administering--- to obviate the objection, but is reminded that the adoption of such suggestion does not necessarily equate to the obviation of any other objection and/or rejection set forth infra.
Claim Rejections - 35 USC § 112(a) (Pre-AIA First Paragraph)
Written Description, New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Applicant’s original claims were filed in the instant application on May 30, 2025 (the actual filing date of the instant application). A subsequent amendment to the claims was filed in the instant application on October 24, 2025 with the response to restriction/election. Applicant is reminded that claims newly presented on October 24, 2025 after the filing of the original disclosure are not part of the original disclosure. See MPEP §714.01(e), which states “[a]ny amendment filed after the filing date of the application is not part of the original disclosure of the application”. As a result, any claims newly added or amended via amendment after the actual filing date in a manner that does not find sufficient support in the originally filed disclosure may be subject to a new matter rejection under 35 U.S.C. §112(a) (pre-AIA first paragraph). See 37 C.F.R. §1.115 and MPEP §608.04(b), §714.01(e) and §706.03(o).
(1) Claims 1-4, 9 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
There is insufficient written support for Applicant’s newly amended limitation directed to the treatment of “cancer-associated inflammation in a patient in need thereof”, in which the patient does not specifically have cancer (claims 1-4, 9, 16).
At p.5 of the Remarks filed October 24, 2025, Applicant states that support for the newly amended claims “can be found in at least ¶¶ [0052], [0055], and [0207]” and “the claims as originally filed”, further asserting that “no new matter is added”.
Applicant’s citations to para.[0052], [0055] and [0207] is in error, as the content of para.[0052] and [0055] do not pertain in any way to the subject matter of the claims as amended, and the originally filed disclosure does not contain para.[0207].
A full and complete consideration of the originally filed disclosure in the instant case identifies the following relevant paragraphs:
(i) In the as-filed specification at p.2-3, para.[0009], Applicant states, “One of the hallmarks of aging is accumulation of senescent cells that contribute to sterile inflammation, which underlies many age-associated diseases … As a result, L1 [long interspersed nuclear element-1, also known as LINE-1 or L1] activity is associated with diseases of aging such as osteoarthritis, cancer, and neurodegeneration”; and
(ii) Applicant states at p.12, para.[0051], “As used herein the term ‘cancer inflammation’ is inflammation that occurs in the context of cancer and may alternatively be defined as ‘cancer-associated inflammation’. Inflammation has been identified as a hallmark of cancer and may be necessary for tumorigenesis and maintenance of the cancer state. Cancer symptoms are associated with inflammation. Thus, a subject with cancer may have or exhibit inflammation, which can be a low-level or peripheral inflammation as discussed above, and in particular a chronic or systemic inflammation as discussed above”.
The disclosure in the as-filed specification describes methods for treating age-associated inflammation via administration of a L1 EN inhibitor and further discloses that diseases associated with aging and L1 activity include cancer. Such disclosure implicitly suggests that the methods as described therein may also be applied to other age-associated diseases in which inflammation plays a role, such as cancer.
However, Applicant’s disclosure of this “cancer-associated inflammation” at p.12, para.[0051] of the as-filed specification makes clear that such inflammation “occurs in the context of cancer”. In other words, such “cancer-associated inflammation” as described in the original disclosure occurs “in the context of” a subject with cancer (thus, “in the context of cancer” as described by Applicant). There is no explicit, implicit or inherent provision in the as-filed specification that supports the treatment of “cancer-associated inflammation” in a patient that does not actually have cancer – such as, e.g., a patient with any one or more of the diseases or disorders recited in claim 2 (aside, of course, from cancer per se). As such, Applicant’s method as now defined in independent claims 1 and 4 circumscribes an impermissible broadening of the subject matter originally disclosed and claimed in the as-filed specification.
As claims 2-3 depend from claim 1, claim 9 depends from claim 4, and claim 16 depends from claim 2, with each propagating this new matter introduced into such respective independent claims, they must also be rejected on the same grounds applied to claims 1 and 4 above.
MPEP §2163 states that “[t]he subject matter of the claim need not be described literally (i.e., using the same terms of in haec verba) in order for the disclosure to satisfy the description requirement.” However, considering the teachings provided in the specification and claims as originally filed, Applicant has failed to provide the necessary teachings by describing the claimed invention in such a way as to reasonably convey to one skilled in the relevant art that Applicant had possession of the concept directed to the treatment of “cancer-associated inflammation in a patient in need thereof”, in which the patient does not specifically have cancer (claims 1-4, 9 and 16).
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 U.S.C. §112(a) (pre-AIA first paragraph).
Claim Rejections - 35 USC § 112(b) (Pre-AIA Second Paragraph)
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.
(2) Claims 3 and 16-18 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.
Applicant’s claim 3 recites “[t]he method of claim 1, wherein the method provides a delaying or a reversing of a progression of an underlying pathology of a disorder caused by cancer-associated inflammation”.
The claim is indefinite because it fails to introduce any further limitation to the active step of the method defined in claim 1 that would account for this additional property (i.e., to delay or reverse progression of an underlying pathology of a disorder caused by cancer-associated inflammation). As a result, it is unclear whether claim 3 is directed to an inherent effect of the method defined by claim 1 (as there is no further active step being performed and such claim would not clearly further limit claim 1), or whether it intends to further limit the claim solely to narrower embodiments of the method that yield this more specific effect (in which case the claim is additionally indefinite for failing to clearly set forth the specific embodiments within the broader scope of claim 1 that function to yield the recited property).
It is additionally unclear if claim 3 requires the patient to also exhibit a disorder that is “caused by the cancer-associated inflammation”, or not.
Clarification is required.
Applicant’s claim 16 recites “[t]he method of claim 2, wherein the cancer undergoes recurrence”.
There is insufficient antecedent basis for the term “the cancer” recited in claim 16 because it is unclear if Applicant is referring to the “cancer” of the “cancer-associated inflammation”, or “cancer” as the disease or disorder of the recited patient. As a result, it is unclear if claim 16 requires the patient to have cancer, or not.
Clarification is required.
It is also unclear if Applicant intends to claim that the “cancer” of the patient to be treated is already a recurrent cancer, or if the “cancer” of the patient becomes recurrent after the L1 EN inhibitor is administered.
Clarification is required.
Applicant’s claim 17 recites “[t]he method of claim 2, wherein the method reduces chemotherapy-induced adverse effects in the patient having cancer”.
The claim is indefinite because it fails to introduce any further limitation to the active step of the method defined in claim 2 that would account for this additional property (i.e., reduction of chemotherapy-induced adverse effects). As a result, it is unclear whether claim 17 is directed to an inherent effect of the method defined by claim 2 (as there is no further active step being performed and such claim would not clearly further limit claim 2), or whether it intends to further limit the claim solely to narrower embodiments of the method that yield this more specific effect (in which case the claim is additionally indefinite for failing to clearly set forth the specific embodiments within the broader scope of claim 2 that function to yield the recited property).
Clarification is required.
Also, it is additionally unclear if claim 17 requires that the “patient having cancer” be actively receiving chemotherapy that induces “adverse effects”, or not.
Clarification is required.
As claim 18 depends from claim 17 and does not remedy this point of ambiguity in such claim, it must also be rejected on the same grounds.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
(3) Claim 8 is 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.
Applicant’s claim 8 recites “[t]he method of claim 6, wherein the patient reports and/or experiences a decrease in one or more symptoms of the cancer after the administration of the AD34 to the patient.”
The claim is indefinite because it fails to introduce any further limitation to the active step of the method defined in claim 6 that would account for this additional property (i.e., a decrease in one or more symptoms of the cancer). As a result, it is unclear whether claim 8 is directed to an inherent effect of the method defined by claim 6 (as there is no further active step being performed and such claim would not clearly further limit claim 6), or whether it intends to further limit the claim solely to narrower embodiments of the method that yield this more specific effect (in which case the claim is additionally indefinite for failing to clearly set forth the specific embodiments within the broader scope of claim 6 that function to yield the recited property).
Clarification is required.
For these reasons, the claim fails to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and is, thus, properly rejected.
(4) Claims 10-11, 13 and 19-21 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.
Applicant’s claim 10 recites “wherein the age-associated inflammation is in a patient having cancer”.
There is insufficient antecedent basis for the term “the age-associated inflammation”, as the preceding text of such claim references only “a cancer-associated inflammation”, not “an age-associated inflammation” per se.
Clarification is required.
Applicant’s claim 11 recites “[t]he method of claim 10, wherein the method provides a delaying or a reversing of a progression of an underlying pathology of a disorder caused by cancer-associated inflammation”.
The claim is indefinite because it fails to introduce any further limitation to the active step of the method defined in claim 10 that would account for this additional property (i.e., to delay or reverse progression of an underlying pathology of a disorder caused by cancer-associated inflammation). As a result, it is unclear whether claim 11 is directed to an inherent effect of the method defined by claim 10 (as there is no further active step being performed and such claim would not clearly further limit claim 10), or whether it intends to further limit the claim solely to narrower embodiments of the method that yield this more specific effect (in which case the claim is additionally indefinite for failing to clearly set forth the specific embodiments within the broader scope of claim 10 that function to yield the recited property).
It is additionally unclear if claim 11 requires the patient to exhibit a disorder distinct from the patient’s cancer already required by claim 10 that is specifically “caused by the cancer-associated inflammation”, or not.
Clarification is required.
Applicant’s claim 19 recites “[t]he method of claim 10, wherein the cancer undergoes recurrence”.
It is unclear if Applicant intends to claim that the “cancer” of the patient to be treated is already a recurrent cancer, or if the “cancer” of the patient becomes recurrent once the L1 EN inhibitor is administered.
Clarification is required.
Applicant’s claim 20 recites “[t]he method of claim 10, wherein the method reduces chemotherapy-induced adverse effects in the patient having cancer”.
The claim is indefinite because it fails to introduce any further limitation to the active step of the method defined in claim 10 that would account for this additional property (i.e., reduction of chemotherapy-induced adverse effects). As a result, it is unclear whether claim 20 is directed to an inherent effect of the method defined by claim 10 (as there is no further active step being performed and such claim would not clearly further limit claim 10), or whether it intends to further limit the claim solely to narrower embodiments of the method that yield this more specific effect (in which case the claim is additionally indefinite for failing to clearly set forth the specific embodiments within the broader scope of claim 10 that function to yield the recited property).
Clarification is required.
Also, it is additionally unclear if claim 20 requires that the “patient having cancer” be actively receiving chemotherapy that induces “adverse effects”, or not.
Clarification is required.
As claim 13 depends from claim 10 and claim 21 depends from claim 20 and such claims not remedy these points of ambiguity, they must also be rejected on the same grounds.
For these reasons, the claims fail to meet the tenor and express requirements of 35 U.S.C. §112(b) (pre-AIA second paragraph) and are, thus, properly rejected.
Claim Rejections - 35 USC § 112(d) (Pre-AIA Fourth Paragraph)
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.
(5) Claims 3, 8, 11, 17-18 and 20-21 are 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.
As set forth in the §112(b) (pre-AIA second paragraph) rejections above, this rejection applies to the interpretation of claims 3, 8, 17 (and by extension claim 18) and 20 (and by extension claim 21) in which they merely define an inherent result of the method from which they each depend and, thus, do not properly further limit the claim from which they each depend.
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 (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 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.
(6) Claims 1-3, 10-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiramoto et al. (“Tranexamic Acid Reduces Endometrial Cancer Effects Through the Production of Angiostatin”, Journal of Cancer, 2022; 13(5):1603-1610).
Hiramoto et al. teaches an experimental study of tranexamic acid (TA) in a chronic inflammation-associated endometrial cancer mouse model, in which the endometrial cancer was induced in the mice by N-methyl-N-nitrosourea (MNU) and estradiol (abstract; col.1, para.2, p.1604-col.2, para.1, p.1604). Hiramoto et al. teaches that the study mice were assigned to three groups: (i) control (n=10), (ii) endometrial cancer (n=10), and (iii) endometrial cancer treated with TA (n=10) (col.1, para.2, p.1604-col.2, para.1, p.1604). Hiramoto et al. teaches that endometrial cancer was induced by MNU and estradiol, after which the mice were orally administered 12 mg/kg TA in 200 mL distilled water three times per week for 30 weeks duration (col.2, para.2, p.1604). Hiramoto et al. teaches that TA treatment effectively decreased levels of CA125, IL-6 and TNF-a levels (which are markers of inflammation; col.2, para.2, p.1605; Fig.3, p.1607). Hiramoto et al. teaches that TA functions to (i) increase levels of plasminogen, but decrease levels of plasmin due to inhibition of plasminogen activator, and (ii) the increase in MMP-12 produced by an increase in macrophages that infiltrate tumor cells functions to degrade this plasminogen to produce angiostatin, wherein angiostatin is known to suppress the proliferation and migration of endothelial cells and inhibit angiogenesis – thus, providing an antitumor effect (col.1, para.1, p.1609-col.2, para.3, p.1609).
Claim 1 recites “[a] method for treating a cancer-associated inflammation in a patient in need thereof” via administering the L1 EN inhibitor AD37 (also known as TA).
Claim 2 specifies that the “cancer-associated inflammation is in a patient” having cancer.
The teachings of Hiramoto et al. provide for the administration of TA to an endometrial cancer-bearing mouse, thereby meeting Applicant’s requirement that AD37 (also known as TA) is administered to a patient having cancer (in this case, the endometrial cancer-bearing mouse).
Hiramoto et al. documents that TA effectively reduces CA125, IL-6 and TNF-a levels in the endometrial cancer mice as compared to control mice, which are known markers of inflammation – thereby further documenting the effect of TA to treat “cancer-associated inflammation” as recited in the preamble objective of claim 1.
Claim 3 depends from claim 1 and recites that “the method provides a delaying or a reversing of a progression of an underlying pathology of a disorder caused by cancer-associated inflammation”.
Applicant’s effect recited in claim 3 is a resultant outcome from administering the claimed L1 EN inhibitor to a patient as provided for in claim 1, which is taught by Hiramoto et al. for the reasons set forth above. As a result, this intended outcome of “delaying or [a] reversing of a progression of an underlying pathology of a disorder caused by cancer-associated inflammation” that results from executing this same active step must necessarily yield from Hiramoto’s teachings because execution of the same active step must yield the same resultant effects.
Claim 10 recites “[a] method for treating a cancer-associated inflammation in a patient in need thereof” that has cancer via administering the L1 EN inhibitor AD37 (also known as TA).
The teachings of Hiramoto et al. provide for the administration of TA to an endometrial cancer-bearing mouse, thereby meeting Applicant’s requirement that AD37 (also known as TA) is administered to a patient having cancer (in this case, the endometrial cancer-bearing mouse).
Hiramoto et al. documents that TA effectively reduces CA125, IL-6 and TNF-a levels in the endometrial cancer mice as compared to control mice, which are known markers of inflammation – thereby further documenting the effect of TA to treat “cancer-associated inflammation” as recited in the preamble objective of claim 10.
Claim 11 depends from claim 10 and recites that “the method provides a delaying or a reversing of a progression of an underlying pathology of a disorder caused by cancer-associated inflammation”.
Applicant’s effect recited in claim 11 is a resultant outcome from administering the claimed L1 EN inhibitor to a patient as provided for in claim 10, which is taught by Hiramoto et al. for the reasons set forth above. As a result, this intended outcome of “delaying or [a] reversing of a progression of an underlying pathology of a disorder caused by cancer-associated inflammation” that results from executing this same active step must necessarily yield from Hiramoto’s teachings because execution of the same active step must yield the same resultant effects.
Claim 13 depends from claim 10 and recites the further “administering of at least one second therapeutic agent to the patient”.
Here, Hiramoto et al. teaches the administration of TA with distilled water, which constitutes the “second therapeutic agent” administered with the L1 EN inhibitor AD37 (also known as TA).
Therefore, instant claims 1-3, 10-11 and 13 are properly anticipated under AIA 35 U.S.C. §102(a)(1).
Conclusion
Rejection of claims 1-4, 8-11, 13 and 16-21 is proper.
Claims 14-15 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
Claim 6 is objected to for depending from a rejected base claim.
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
February 4, 2026