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 1-9 are pending and currently under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). However, no certified copy of the foreign priority documents have been file in this application. Consequently, the priority date of the 5-20-2025 will be used. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation will result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The Information Disclosure Statements filed on 5-27-2025 and 10-13-2025 have been considered. Initialed copies are attached hereto.
It should be noted that 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, they have not been considered.
Claim Objections
Claims 1-4, 7 and 9 are objected to for utilizing the acronym “SEMA4D” without defining it upon its first recitation.
Claims 8 and 9 are objected to for utilizing the acronym “CXCL12” without defining it upon its first recitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Laws of nature or natural phenomena include naturally occurring principles/ relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP2106.04(b)).
“The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter" under Section 101. Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). "Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Id. Nor can one patent "a novel and useful mathematical formula," Parker v. Flook, 437 U.S. 584, 585, 198 USPQ 193, 195 (1978); electromagnetism or steam power, O’Reilly v. Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or "[t]he qualities of ... bacteria, ... the heat of the sun, electricity, or the qualities of metals," Funk, 333 U.S. at 130, 76 USPQ at 281; see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1853).”
Products of nature are analyzed under 35 USC 101 through the “markedly different characteristics analysis”. MPEP 2106.04(c) as a part of step 2A prong one of the analysis.
“If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). For claims where the entire claim is a single nature-based product (e.g., a claim to "anti-SEMA4D and anti-CXCL12 antibody "), once a markedly different characteristic in that product is shown, no further analysis would be necessary for eligibility because no product of nature exception is recited (i.e., Step 2B is not necessary because the answer to Step 2A is NO). For claims including limitations in addition to the nature-based product, further eligibility analysis is required.
If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.
Claims 1-9 recite the following natural product: An “anti-SEMA4D antibody” and claim 8-9 additional recite an “anti-CXCL12 antibody”.
MPEP2106.04(C) II sets forth:
Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include:
• Biological or pharmacological functions or activities;
• Chemical and physical properties;
• Phenotype, including functional and structural characteristics; and
• Structure and form, whether chemical, genetic or physical.
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.” (MPEP2106.04 (c)II. C).
Comparing the relevant characteristics between the products of claims 1-9 and its naturally occurring counterpart, the examiner finds no markedly difference characteristics between the characteristics of the two.
If there are no markedly different characteristics between the product of the claim and the naturally occurring counterpart, the claim is probed for the presence of additional limitations. The claimed additional elements are analyzed alone or in combination to determine if the natural product is sufficiently different than is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the natural product, the claim fails to integrate the natural product into a practical application (MPEP 2106.04(d).III).
There are no additional limitations to the natural products in claim 1-9.
The recitation of the phrase “for preventing or treating Sjogren’s syndrome” is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “formulated for administration by injection…” is not considered an additional limitation as it conveys no structural limitations.
The recitation of the phrase “is administered locally into a salivary gland” is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “diagnostic kit for Sjogren’s syndrome” is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
Considering the additional limitations in addition to the natural product together as a whole, the additional elements do not rise to the level of significantly more than the natural product.
In combination, the lack of additional limitations, acted upon by the judicial exception (or natural law, or natural product), fail to rise to the level of significantly more. No additional limitation has clearly been identified.
The claims have all been examined to identify the presence of a naturally occurring product or natural phenomena. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found lacking.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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 1-9 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.
Claim 1 is rendered vague and indefinite by the use of the phrase “...anti-SEMA4D blocking antibody…”. It is unclear what is meant be engendered by said phrase. Is the claimed antibody supposed to bind to SEMA4D or to an antibody that binds SEMA4D? As written, it is impossible to determine the metes and bounds of the clamed invention.
Claim 2 is rendered vague and indefinite by the use of the phrase “...anti-SEMA4D blocking antibody…”. It is unclear what is meant be engendered by said phrase. Is the claimed antibody supposed to bind to SEMA4D or to an antibody that binds SEMA4D? As written, it is impossible to determine the metes and bounds of the clamed invention.
Claim 3 is rendered vague and indefinite by the use of the phrase “...anti-SEMA4D blocking antibody…”. It is unclear what is meant be engendered by said phrase. Is the claimed antibody supposed to bind to SEMA4D or to an antibody that binds SEMA4D? As written, it is impossible to determine the metes and bounds of the clamed invention.
Claim 4 is rendered vague and indefinite by the use of the phrase “...anti-SEMA4D blocking antibody…”. It is unclear what is meant be engendered by said phrase. Is the claimed antibody supposed to bind to SEMA4D or to an antibody that binds SEMA4D? As written, it is impossible to determine the metes and bounds of the clamed invention.
Claim 7 is rendered vague and indefinite by the use of the phrase “...anti-SEMA4D blocking antibody…”. It is unclear what is meant be engendered by said phrase. Is the claimed antibody supposed to bind to SEMA4D or to an antibody that binds SEMA4D? As written, it is impossible to determine the metes and bounds of the clamed invention.
Claim 8 is rendered vague and indefinite by the use of the term “…CXCL12 antibody…”. It is unclear whether said term is referring to the name of the antibody or to what it binds. If the latter is the case, it is suggested that the term “anti-CXCL12 antibody” be used instead.
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 9 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. The phrase “… wherein the diagnosis of Sjogren’s syndrome is performed by measuring levels of soluble SEMA4D and CXCL12 in saliva…” does not constitute a claim limitation. Consequently, the claim is limited a kit comprising an anti-SEMA4D antibody and an anti-CXCL12 antibody. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al. (Annals of Rheumatic Diseases, Vol. 79, page 1367 – IDS filed on 5-27-2025).
Kang et al. disclose the use of anti-SEMA4D antibodies in an ELISA assay to detect SEMA4D (CD100) in human plasma.
The recitation of the phrase “for preventing or treating Sjogren’s syndrome” in claim 1 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “is administered locally into a salivary gland” in claim 6 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “diagnostic kit for Sjogren’s syndrome” in claim 7 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations. Consequently, Kang et al. anticipates all the limitations of the rejected claims.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feigin et al. (Nature Medicine, Vol. 28, pages 2183-2193).
Feigin et al. disclose compositions comprising the Pepinemab antibody (see abstract). Feigin et al. further disclose that Pepinemab is a humanized IgG4 monoclonal antibody and that the antibody was administered intravenously (see page 2190).
The recitation of the phrase “for preventing or treating Sjogren’s syndrome” in claim 1 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “is administered locally into a salivary gland” in claim 6 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “diagnostic kit for Sjogren’s syndrome” in claim 7 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations. Consequently, Feigin et al. anticipates all the limitations of the rejected claims.
Claim Rejections - 35 USC § 103
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 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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over by Feigin et al. (Nature Medicine, Vol. 28, pages 2183-2193) and Liao et al. (Frontiers in Immunology Vol. 15, pages 1-14).
Feigin et al. disclose compositions comprising the Pepinemab antibody (see abstract). Feigin et al. further disclose that Pepinemab is a humanized IgG4 monoclonal antibody and that the antibody was administered intravenously (see page 2190).
Feigin et al. differs from rejected claims 8 and 9 in that they don’t explicitly disclose compositions comprising anti-CXCL12.
Liao et al. disclose that CXCL12 is associated with the survival of malignant B cell in the salivary glands of patients with Sjogren’s syndrome and mucosa-associated lymphoid tissue (see page 4).
Consequently, it would have been obvious for one of ordinary skill in the art to combine the anti-SEMA4D antibody of Feigin et al. with the anti-CXCL12 antibody suggested by Liao et al. in order to more effectively treat a patient with Sjogren’s syndrome and mucosa-associated lymphoid tissue.
One would have had a reasonable expectation of success as given both SEMA4D and CXCL12 are involved in Sjogren’s syndrome and associated maladies.
The recitation of the phrase “is administered locally into a salivary gland” in claim 6 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
The recitation of the phrase “diagnostic kit for Sjogren’s syndrome” in claim 7 is not considered an additional limitation as it constitutes an intended use and conveys no structural limitations.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 August 1, 2026
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