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 .
Election/Restrictions
Applicant's election with traverse of Group XXXV (a composition comprising at least Zn) as applicant has requested in the reply filed on 8/7/26 is acknowledged. The traversal is on the ground(s) that the restriction over fragmented the invention however the way applicant’s claims are drafted necessitated the restriction because of the amount of distinct inventions claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 are examined on the merits as they read on the elected invention, i.e. a pharmaceutical composition for modulating inflammation and oxidative stress in mammals including at least Zn.
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 1-4 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 appear to be drafter broader than what applicant would define their invention as and as such the claims fail to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. The instant claim 1 requires only a singular cation, e.g. H, which in most cases would read on a product of nature and also not be effective for “modulating inflammation and oxidative stress in mammals.” In their argument about the restriction requirement, applicant argues “In the context of the claimed invention, the relevant genus may be divided into
two scientifically coherent subclasses: cationic species and anionic species. The
examiner-designated element-by-element division, therefore, does not reflect the
common inventive concept. The physiologically relevant distinction is not the mere identity of each element in isolation, but how the species behaves under physiological conditions in relation to the claimed modulation of inflammation and oxidative stress.” which would suggest that the subject matter applicant regards as their invention is mote than is claimed.
Please note that the language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973). The courts have also indicated that before claimed subject matter can properly be compared to the prior art, it is essential to know what the claims do in fact cover. See, e.g., the following decisions: In re Steele, 305 F 2d. 859, 134 USPQ 292 (CCPA 1962); In re Moore 439 F 2d. 1232, 169 USPQ 236 (CCPA 1969); In re Merat, 519 F 2d. 1390, 186 USPQ 471 (CCPA 1975).
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 1-4 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by
US 2022/305054 (NOVAK et al) 29 September 2022, WO 2021/211660 (VECTOR) 21 October 2021
Novak teaches a composition comprising ⁶⁴Zn which is at least 80% enriched (and in combination with aspartate) that is anti-inflammatory as well modulating of oxidative stress [215-232]; [table 10].
Vector also teaches a composition of Zn which is ⁶⁴Zn-enriched and in the form of Zn⁶⁴citrate or glycine-methionine, wherein the Zn is at least 80% enriched and in a carrier such as water. Compositions are shown to have anti-inflammatory activities and result in a reduction of oxidative stress [par.35-45; 66; Table 16, 17; par. 238-251].
The references anticipate the claim subject matter.
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.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/305054 (NOVAK et al) 29 September 2022, WO 2021/211660 (VECTOR) 21 October 2021 & Albarede et al Review in Minerals & Geochemistry.
Novak teaches a composition comprising ⁶⁴Zn which is at least 80% enriched (and in combination with aspartate) that is anti-inflammatory as well modulating of oxidative stress [215-232]; [table 10].
Vector also teaches a composition of Zn which is ⁶⁴Zn-enriched and in the form of Zn⁶⁴citrate or glycine-methionine, wherein the Zn is at least 80% enriched and in a carrier such as water. Compositions are shown to have anti-inflammatory activities and result in a reduction of oxidative stress [par.35-45; 66; Table 16, 17; par. 238-251].
Novak and Vector don’t teach ⁶6Zn or all the combinations as claimed with the other active components however it would have been obvious at the time the invention was made to enrich a composition with either claimed Zn isotope because Albarede teaches that ⁶6Zn is also a known isotope of Zn and has functional properties such as the isotope used in Novak and Vector [Table 1, p 861-62] and would be usable as ⁶⁴Zn is. Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Further it is obvious to combine medicants with known medications that are to perform the same utility or act an adjuvants or otherwise increase the pharmaceutical benefit of the active ingredient. It is a well established proposition of patent law that no patentable invention resides in combining old ingredients of known characteristics where the results obtained thereby are no more than the additive effect of the ingredients. See In re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; In re Crockett et al, 1266 USPQ 186.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a composition of a naturally occurring Zn isotope. This judicial exception is not integrated into a practical application because the claims are drawn to the composition per se. The claims are drawn to a composition of matter however the claims are drawn to a natural phenomenon, namely the occurrence in nature of The Zn isotopes. The instant specification describes the invention as being composed of all those isotopes
The specification contains no evidence, that the method of making the composition imparts characteristics markedly different from those isotopes as they exist and function in nature. As such, there is no evidence that the claimed population or composition of the population has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring isotopes. For these reasons, the claimed invention does not appear to have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
The claims do not include additional elements that aren’t also natural products that are sufficient to amount to significantly more than the judicial exception because the claimed invention does not include any additional features that could add significantly more to the exception, so the claim does not qualify as eligible subject matter.
Concluding the analysis, the claimed invention is drawn to a judicial exception to the statute and must be rejected as ineligible under 35 USC101.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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