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 Claims
Claims 1-5 are now pending and will be examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/18/2024 has been considered here.
Claim Rejections - 35 USC § 112: Scope of Enablement
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.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of neuroprotection for any one of the treatment of a stroke, a cerebral infarction, thrombosis, cerebral degenerative disease, vascular dementia, memory loss, short-term memory impairment, a concentration disorder, anxiety, and nervousness; brain damage protection; brain function improvement; and cranial nerve cell protection, through the activation of neuroglobin (Ngb), comprising administering to a subject in need thereof a Maclura pubescens extract or fraction thereof; or a Prunus cerasoides extract or fraction thereof , does not reasonably provide enablement for any and all methods of neuroprotection for any one of the treatment and prevention of a stroke, a cerebral infarction, thrombosis, cerebral degenerative disease, vascular dementia, memory loss, short-term memory impairment, a concentration disorder, anxiety, and nervousness; brain damage protection; brain function improvement; and cranial nerve cell protection, through the activation of neuroglobin (Ngb), comprising any and all methods of administering to a subject in need thereof a Maclura pubescens extract or fraction thereof; or a Prunus cerasoides extract or fraction thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The enablement requirement is considered based on the following eight Wands factors (MPEP 21.64.01(a)): (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims: The scope of the instant claims are broad and read on any and all types of extracts of either Maclura pubescens or Prunus cerasoides in any and all routes of administration. Instant claim 1 claims “for a method of neuroprotection for any one of the treatment and prevention of a stroke, a cerebral infarction, thrombosis, cerebral degenerative disease, vascular dementia, memory loss, short-term memory impairment, a concentration disorder, anxiety, and nervousness; brain damage protection; brain function improvement; and cranial nerve cell protection,”, which is not supported by the instant specification.
The nature of the invention, and Breadth of the claims: The claim invention is directed to a method of neuroprotection for any one of the treatment and prevention of a stroke, a cerebral infarction, thrombosis, cerebral degenerative disease, vascular dementia, memory loss, short-term memory impairment, a concentration disorder, anxiety, and nervousness; brain damage protection; brain function improvement; and cranial nerve cell protection, through activation of neuroglobin. The claim encompasses prevention of disorders that may have potential causes other than those disclosed in the specification. This may or may not be addressed by the administration of the claimed composition. Moreover, the specification is directed to treating the claimed conditions by the instant composition. The claims encompass prevention of medical conditions in susceptible patients, and the burden of enabling prevention of conditions would be greater than that of enabling a treatment due to the need of additional testing and screening to those humans and dogs susceptible to conditions that may or may not happen. Prevention of medical conditions may not be addressed by the administration of the instantly claimed composition, not their cure, only treatment.
The state of the prior art and The level of predictability in the art: The art teaches that activation of neuroglobin is known to have neuron protective effects in animals and that Prunus cerosoides is able to activate neuroglobin (see WO 2017065514 A1 (Chang, 2017; machine translation provided from FIT via PE2E; page 11, point 6). Further, the extract of Prunus cerosoides is known to lower neuro-behavioral scores for aging damage (see Kim (2017); as submitted on IDS of 11/18/2024 (copy not submitted in instant application, however is found in parent application 17/286253); page 61). The extract and its positive effect on the activation of neuroglobin is known in the art, however, there is no support in the instant specification that all delivery routes/types will result in the same outcome with absolute predictability, as a result one of ordinary skill in the art would have to result to trial and error experimentation in order to practice the invention commensurate in scope with the claims. Based on all the data presented in the references above, the Examiner deems the art as highly unpredictable since it is unknown if any and all methods of administration will treat or prevent any and all types of the disorders/conditions listed in claim 1.
The amount of direction provided and The existence of working examples: There is no evidence in the specification that the instant invention is capable of working or used with any and all of types of administration to prevent any and all of the disorders/conditions listed in claim 1. The working examples are testing the neuroprotective effects of the extracts of claim 1 on various proteins from specific cell lines and mice. There is no data presentation on the prevention of the disorders/conditions listed in claim 1.
The quantity of experimentation needed to make or use the invention: Given the breadth of the claims and the data presented above, one of ordinary skill would have to undertake a burdensome amount of research to show how each and every method of administration of the extracts would achieve the same functions when administered via each and every route of administration to different subjects presenting any and all types of the conditions listed in claim 1. It is not clear what specific embodiments would be required in order for one of ordinary skill in the art to practice the instant invention commensurate in scope with the claims.
The level of one of ordinary skill: The level of one of ordinary skill is high, i.e. advanced education and training.
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 1-5 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more. [emphasis added to reflect newly presented claims]
The claims recite natural phenomena. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP §2106:
PNG
media_image1.png
791
541
media_image1.png
Greyscale
PNG
media_image2.png
524
532
media_image2.png
Greyscale
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an
abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP §2106.05(a)
Applying the judicial exception with, or by use of, a particular machine. See MPEP §2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP §2106.05(c)
Applying or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. See MPEP §2106.05(d)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP §2106.05(e)
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1): The answer to this step is yes since claims 1-5 are directed to a method (i.e., a process), which is a statutory category.
Step (2A): The answer to this step is yes because the claimed processes are directed to laws of nature and natural phenomena, specifically a Maclura pubescens extract or fraction thereof or a Prunus cerasoides extract or fraction thereof (claims 1-5).
Prong 1:
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Independent claim 1 recites “A method of neuroprotection …comprising administering to a subject in need thereof a Maclura pubescens extract or fraction thereof; or a Prunus cerasoides extract or fraction thereof.”
In the instant case, the scope of the positively recited elements of the compositions defines them in terms of naturally-occurring compounds, and as such the pharmaceutical composition and food composition are defined as consisting of naturally-occurring compounds. The composition of the claims is merely taking naturally occurring materials and combining them, which does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product of nature a particular technological environment. The dependent claims 3-5 teach further forms of the composition that is administered however the limitations do not significantly change the composition in a meaningful way.Thus these are not significant additions to the naturally-occurring compound. In regards to the method of extraction of claim 2, simply concentrating the naturally-occurring compound does not constitute a significant difference from the naturally-occurring compound.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application.
Here, the instantly amended claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claims 1-5 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, the answer to step 2A prong 2 is no.
Step (2B):
Claims 1-5 do not recite additional elements which require analysis under step 2B. At most, claims 4-5 teach liquids, capsules, beverages, and food additives, which are not significantly different as these forms are achieved by having the extract in water, which is also a naturally occurring compound. Thus, these are not significant additions to the limitations of the claims.
Therefore, the answer to step (2B) is no.
Conclusion
Claims 1-5 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
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.
(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 and 3-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (2017; as submitted on IDS of 11/18/2024; copy not submitted in instant application, however is found in parent application 17/286253).
In regards to claim 1, Kim teaches a composition comprising an orally administered (i.e., a pharmaceutical composition or a food composition) Prunus cerasoides extract that upregulates neuroglobin (ngb) (see Kim, page 68). It is taught that the extract is able to lower neuro-behavioral score for aging damage (see Kim, page 61). It is taught that the neuro-behavioral levels include anxiety, as such lowering the score would be understood as lowering anxiety levels as well (see Kim, page 61).
In regards to claims 3-5, it is taught that the extract is administered to mice in the form of a liquid orally (i.e., a beverage or food additive) (see Kim, page 77).
Claims 1 and 3-5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2017065514 A1 (Chang, 2017; machine translation provided from FIT via PE2E).
In regards to claim 1, Chang teaches a composition comprising Prunus cerasoides extract (see abstract) that causes the expression of ngb mRNA (i.e., upregulates ngb) (see page 12, paragraphs 2-3). It is taught that the ngb activation has neuron protective effects in stroke animal models (see page 11, point 6).
In regards to claims 3-5, the composition is taught to be used in functional food and medicinal (i.e. pharmaceutical) fields (see abstract). Chang also teaches examples of the extract in tablets, capsules, powders, and liquid/beverage form (see pages 19-20, formulations 1-5). Further it is taught that the composition is in the form of tablets, capsules, granules, liquids, pills, beverages, powdered drinks, solids, chewing gum, tea, vitamin complexes, and food additives (see page 8, paragraphs 6-7).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claim 2 recites a method of neuroprotection wherein the extract of interest is obtained by an ultrasonic extraction at 30°C to 60°C for 2 to 4 days using methanol or ethanol as an extraction solvent. It is noted that similar methods are known in the art, specifically ultrasonic extraction using ethanol as a solvent at 60°C (see Sharma (2018); page 1484, Preparation of P. cerasoides fruit extract (PCFE)), however the methods known in the prior art do not teach ultrasonic extraction for 2 to 4 days. As such, at this time the limitation of claim 2 seems to be free of the art. However it is noted that the issues under USC 101 and 112 are still present in claim 2.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
Prosecution Insights