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 .
Priority
The instant application is a CIP of international application No. PCT/CN2022/084968, filed April 2, 2022, which claims priority under 35 USC 119(a)-(d) from Chinese Application CN 202110362273.0, filed April 2, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 2, 2023 and November 6, 2023 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Restrictions/Elections
Applicant’s election of compound 85
PNG
media_image1.png
79
64
media_image1.png
Greyscale
, chemical name 1,7,7-trimetthylbicyclo[2.2.1]heptan-2-one, common name camphor, in the reply filed March 2, 2026 is acknowledged.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: the elected species was not found to be allowable over the prior art. Thus, the scope of the search and examination weas not expanded beyond the elected species of camphor.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to products having the formula I, classified in A61K31/122.
II. Claim 18, drawn to a method of using the products of Group I, classified in A61P.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the products can be used for a number of distinct processes. For example, camphor can be used for odor elimination, aromatherapy or pain relief.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
In the written response to election of species requirement (March 2, 2026) a provisional election was made with traverse to prosecute the claims drawn to compounds (defined by Group I) for substantive examination (p. 46/46). Affirmation of this election must be made by applicant in replying to this Office action. Claim 18 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Status of Claims
Currently, claims 1-18 are pending in the instant application. Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Claims 1-17 read on an elected invention and species and are under consideration herein to the extent they read on the elected species.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-17 are directed to a natural product and does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites at least the compound camphor
PNG
media_image1.png
79
64
media_image1.png
Greyscale
. As evidenced by the teachings of Kareem et al., camphor is found in extracts of flowers of Chrysanthemum cinerariaefolium (see Table 2). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the compounds, as claimed, occur in nature so there are no additional elements to be considered and the claim is not patent eligible.
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 1-17 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 pre-AIA the applicant regards as the invention.
In particular, the claims are indefinite because of the recitation of a “metabolite…thereof” of the claimed compounds. In order for a claim to a chemical entity to be clear and definite, a person of ordinary skill in the art must be able to fully ascertain the metes and bounds of the claimed structure. With respect to the claimed metabolites, this term includes any compound which can be produced from the in vivo breakdown or metabolism of the claimed compounds. However, there is no disclosure of the particular metabolic pathway of the instant compounds, nor would it be possible to know every single enzyme which could potentially react with and thus transform the instant compounds in vivo. Without the particular information including which enzymes will necessarily act on the claimed compound, and what particular chemical transformation occurs as a result of this action, it is not possible for the skilled artisan to determine which particular compounds are embraced by the claimed “metabolite" and the use of the term renders the claim indefinite.
Claims 11, 14 and 15 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 claims 11, 14 and 15, the phrase "include" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 5-6 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.
The claims are indefinite because many of the compounds listed in the claim, including the compound numbers, are blurry and illegible. For example, on page 9/46 of the claim set,
PNG
media_image2.png
100
95
media_image2.png
Greyscale
and
PNG
media_image3.png
84
84
media_image3.png
Greyscale
are depicted. Further, on page 24/46 of the claim set,
PNG
media_image4.png
75
88
media_image4.png
Greyscale
. As another example, on page 20/46, the claim set depicts
PNG
media_image5.png
227
82
media_image5.png
Greyscale
. There are many examples of blurry and illegible structures throughout the claim set. All must be corrected in order to overcome this rejection.
Claim Rejections – 35 USC § 102
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 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN106902239. Please note that the machine translation is relied upon in describing the relevant anticipatory teachings of the prior art.
The ‘239 publication teaches a Chinese medicine for treating coma. As particular embodiments (also reading instant claim 16 which requires the product to be in a pill or tablet form, for example), the prior art teaches a capsule containing camphor (embodiment 1), a granule containing camphor (embodiment 2) and a tablet containing camphor (embodiment 3). Each instance anticipates the instant claim to an antagonist against anesthsia or sedative comprising a compound of Formula I, since camphor is a compound of Formula I and the elected species. Notably, in Formula I, R0, R8 and R9 are methyl, m is 1, n is 1, and each of R1-R7 and R10 is H.
With respect to the following limitations: “antagonist against anesthesia and/or sedative,” the product “can reverse the anesthetic and/or sedative state,” “can reduce the duration of anesthesia and/or sedation,” ands “GABAA receptor agonist,” “Products of identical chemical composition can not have mutually exclusive properties" (MPEP 2112.01(II)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure as that recited in the claim, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). Even if that property (i.e. particle size, hydrophobicity, injectability) is not disclosed in the prior art, if the chemical structure is identical, the art need not recognize every property of the compound in order to render it unpatentable. In accordance with MPEP 2112, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Since the prior art teaches all required features of the instantly claimed invention, the claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALICIA L OTTON/Primary Examiner, Art Unit 1699
Prosecution Insights