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 1-8 are presented for examination.
Acknowledgement is made of the present application as a continuation of PCT Application No. PCT/CN2022/072881, filed January 20, 2022, which claims benefit under 35 U.S.C. §119(a-d) to Chinese Patent Application No. 202110140223.8, filed February 2, 2021. Receipt is acknowledged of a certified copy of the ‘223.8 Chinese application filed in the instant application on September 18, 2023 as required by 37 C.F.R. §1.55.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed July 20, 2023 (five pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08, the Examiner has considered the cited references.
Priority
Acknowledgement is made of the present application as a continuation of PCT Application No. PCT/CN2022/072881, filed January 20, 2022, which claims benefit under 35 U.S.C. §119(a-d) to Chinese Patent Application No. 202110140223.8, filed February 2, 2021. 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).
As Applicant’s prior-filed PCT Application No. PCT/CN2022/072881, filed January 20, 2022, and Chinese Patent Application No. 202110140223.8, filed February 2, 2021, are not filed in English and a certified English language translation of the same has not been provided, these earlier filed applications cannot be fully evaluated to determine sufficiency of support for the claimed subject matter.
As a result, instant claims 1-8 are not afforded the benefit of the earlier filing dates of the ‘881 PCT application or the ‘223.8 foreign application.
Accordingly, the effective filing date of claims 1-8 under examination is July 20, 2023 (the filing date of the instant application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Objections to the Claims
Claim 2 is objected to for failing to recite the conjunction “or” between the final two dosage ranges of the list.
Appropriate correction is required.
Claim 3 is objected to for failing to recite a conjunction between the “said accompanying symptoms” definition and the “said menstrual abnormalities” definition at l.3 of the claim.
Appropriate correction is required.
Claim 3 is also objected to for reciting “said accompanying symptoms” in plural form, but then reciting only a single symptom.
Appropriate correction is required.
Claim 4 is objected to for reciting “wherein at least one of the following benefits is achieved by the patient after the preventing, alleviating or treating”, which is grammatically awkward.
Appropriate correction is required.
Applicant may wish to consider amending the claim to recite ---wherein at least one of the following benefits is achieved by the patient following administration---, 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 4 is objected to for reciting “the amount of menstrual bleeding is reduced to no more than 50%, 40%, 30%”, which is grammatically awkward.
Appropriate correction is required.
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.
(1) Claims 1-8 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 1 recites “[a] method for preventing, alleviating or treating disease in a patient”.
It is unclear if the “patient” of claim 1 is, in fact, in need of the recited objective of “preventing, alleviating or treating disease”, or is any patient.
Clarification is required.
As claims 2-8 do not remedy this point of ambiguity in claim 1, they must also be rejected on the same grounds applied thereto.
Applicant’s claim 1 requires a step of “administering to the patient a prophylactic, alleviating or therapeutic amount of at least one of pyrroloquinoline quinone [PQQ] or a derivative thereof”.
The limitation “or a derivative thereof” renders the claim indefinite because the objective boundaries of the recited “derivatives” permitted by the claim is not clearly set forth. There is no indication of the degree of derivatization that the recited “derivative” may have from the parent PQQ – e.g., which moieties may be changed or appended, which moieties must be preserved, etc. – and constitute a “derivative” within the meaning of the claim. As a result, the determination of the scope of “derivatives” circumscribed by the objective boundaries of the claim would rely on the subjective interpretation of the ordinarily skilled artisan before the effective filing date of the claimed invention and, thus, fails to clearly and precisely define the metes and bounds of the claimed subject matter.
MPEP §2173.05(b)(IV) clearly states that “[c]laim scope cannot depend solely on the unrestrained subjective opinion of a particular individual purported to be practicing the invention” (citing to Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)).
Clarification is required.
As claims 2-4 and 8 do not remedy this point of ambiguity in claim 1, they must also be rejected on the same grounds applied thereto.
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.
(2) Claims 2-4 and 6 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 2 recites “wherein the oral dosage based on pyrroloquinoline quinone is: about 5 mg/day to about 10 mg/day for preventing of primary dysmenorrhea or secondary dysmenorrhea; about 15 mg/day to about 20 mg/day for alleviating or treating mild dysmenorrhea; about 20 mg/day to about 30 mg/day for alleviating or treating moderate dysmenorrhea; about 25 mg/day to about 100 mg/day for alleviating or treating severe dysmenorrhea; about 20 mg/day to about 50 mg/day for alleviating or treating menstrual abnormalities”.
There is insufficient antecedent basis for the term “the oral dosage” at l.1 of the claim, because the preceding text of claim 2 and claim 1 (from which claim 2 depends) fails to reference “an oral dosage” per se. As a result, it is unclear if Applicant intends to limit the method to oral administration or not.
Clarification is required.
Also, Applicant references “mild dysmenorrhea”, “moderate dysmenorrhea” and “severe dysmenorrhea” at l.4-6 of claim 2, but it is unclear if this “mild”, “moderate” or “severe” characterization applies to (i) primary dysmenorrhea, (ii) secondary dysmenorrhea, or (iii) primary or secondary dysmenorrhea.
Clarification is required.
Also, it is unclear if there are specific, objective criteria that distinguish “mild”, “moderate” and “severe” forms of dysmenorrhea from one another, or whether such characterization is based only on a subjective assessment of pain.
MPEP §2173.05(b)(IV) clearly states that “[c]laim scope cannot depend solely on the unrestrained subjective opinion of a particular individual purported to be practicing the invention” (citing to Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)).
Clarification is required.
Applicant’s claim 3 defines the “said accompanying symptoms of secondary dysmenorrhea” as “infertility caused by the treatment of secondary dysmenorrhea”.
It is unclear if “the treatment of secondary dysmenorrhea” refers to the treatment of claim 1 using PQQ, or some other unidentified – but previously administered – treatment of secondary dysmenorrhea (in which case the claim is additionally indefinite for failing to clearly identify this treatment).
Clarification is required.
Applicant’s claim 3 defines the “said menstrual abnormalities” as “at least one of abnormal increase in the amount of menstrual bleeding, an abnormal increase in the duration of menstrual bleeding, and the menstrual cycle longer than 35 days”.
The term “abnormal increase” as used to define “the amount of menstrual bleeding” or “the duration of menstrual bleeding” is a relative term without a defined standard to identify the requisite “increase” in amount or duration of menstrual bleeding. Also, as menstrual cycles – including the amount and duration of menstrual bleeding – vary by individual, it is unclear what amount of “increase” in amount or duration of “menstrual bleeding” would constitute a “normal” or “abnormal” increase as instantly claimed.
Clarification is required.
Applicant’s claim 4 recites various benefits “achieved by the patient”, including “alleviation of dysmenorrhea, preferably the average score of menstrual dysmenorrhea pain index drops by more than 1 point or the pain level drops by one grade”.
There is insufficient antecedent basis for the term “the average score of menstrual dysmenorrhea pain index” as recited at l.4-5 of the claim.
Clarification is required.
Also, it is unclear over what period of time this “average score” is assessed, as an average necessarily requires multiple data points and Applicant fails to define at what points in time the pain index is to be assessed to determine this average value.
Clarification is required.
Applicant’s use of the term “preferably” also fails to clearly set forth whether the limitations that follow such term are merely exemplary of the desired effect, or if they limit the claim specifically to this narrower “preferable” effect.
Clarification is required.
Applicant’s claim 4 recites various benefits “achieved by the patient”, including “the amount of menstrual bleeding is reduced to no more than 50%, 40%, 30% of the normal menstrual bleeding of women, preferably 10%, and more preferably reduced to of normal average menstrual bleeding”.
The term “normal menstrual bleeding of women” or “normal average menstrual bleeding” are relative terms without defined standards to define what is considered “normal” or “normal average” (and what is considered “abnormal” or “abnormal average”). Also, as stated above, menstrual cycles – including the amount of menstrual bleeding – vary by individual, so it is unclear what amount of menstrual bleeding would constitute a “normal” or “normal average” amount as instantly claimed. Without identifying these “normal” or “normal average” amounts of menstrual bleeding, the ordinarily skilled artisan would be unable to identify the amounts that would then constitute a reduction of 50%, 40%, etc. as recited in claim 4.
Clarification is required.
Also, Applicant’s use of the term “preferably” and “more preferably” fails to clearly set forth whether the limitations that follow such terms are merely exemplary of the desired effect, or if they limit the claim specifically to this narrower “preferable” or “more preferable” effect.
Clarification is required.
Applicant’s claim 4 recites various benefits “achieved by the patient”, including “said duration of menstrual bleeding is shortened to no longer than 10 days, preferably to no longer than 9 days, 8 days, or 7 days”.
Applicant’s use of the term “preferably” fails to clearly set forth whether the limitations of “no longer than 9 days, 8 days, or 7 days” is merely exemplary of the desired duration of menstrual bleeding, or if the claim is specifically limited to this narrower duration.
Clarification is required.
Applicant’s claim 6 recites “wherein said derivative of [PQQ] is a derivative hydrolysable to [PQQ] in digestive tract”.
It is unclear if the PQQ derivative must be hydrolysable in the digestive tract of the patient receiving the administration step, or any other unidentified digestive tract.
Clarification is required.
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 4 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 4 recites various benefits that yield from practicing the method as provided for in instant claim 1.
The claim is indefinite because it fails to introduce any further limitation to the active step of the method in claim 1 that would yield the “benefits” of claim 4. As a result, it is unclear whether claim 4 is directed to inherent effects of the method defined by claim 1 (as there is no further active step performed, then claim 4 would not clearly further limit claim 1), or whether it intends to further limit the claim to narrower embodiments of the method of claim 1 that yield these specific effects (in which case the claim is additionally indefinite for failing to clearly set forth the specific embodiments within the broad scope of claim 1 that yield the recited effects).
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.
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.
(4) Claim 4 is 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) rejection above, this rejection applies to the interpretation of claim 4 in which it defines inherent effects of the method of claim 1 and fails to provide any further limitation of the method consistent with the requirements of 35 U.S.C. §112(d) (pre-AIA fourth paragraph).
Clarification is required.
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.
(5) Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al. (U.S. Patent No. 10,959,998 B2; 2021), citing to Harada (“Dysmenorrhea and Endometriosis in Young Women”, Yonago Acta Medica, 2013; 56:81-84) as factual evidence.
Wen et al. teaches the medicinal use of PQQ or its derivative and/or salt forms thereof for the treatment and/or prevention of endometriosis (abstract; col.1, l.16-21; col.4, l.30-34; col.4, l.51-55; col.5, l.21-24). Wen et al. teaches that PQQ or its derivative and/or salt forms have the chemical structure of formula (I), which is
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, wherein R1, R2 and R3 are the same or different, and are each independently selected from lower alkyl, lower alkenyl, lower alkynyl, alkaryl, aralkyl, benzyl, hydrogen, Na and K, and include specific embodiments in which R1, R2 and R3 are each hydrogen (the structure of PQQ per se) or the disodium salt of PQQ (col.3, l.35-col.4, l.2; col.5, l.49-col.6, l.3). Wen et al. teaches that the administration of PQQ to an endometriosis patient is effective to improve fertility and increases the chances of pregnancy as compared to existing drug therapies used clinically in the treatment of endometriosis (col.5, l.17-20). Wen et al. teaches that PQQ may be further combined with an antioxidant, such as N-acetyl-L-cysteine, resveratrol, epigallocatechin gallate, curcumin, anthocyanidin, vitamin E or vitamin C (col.5, l.44-49). Wen et al. teaches that an adult dose of PQQ is about 2-20 mg/day (col.17, l.15-23). Wen et al. further teaches that PQQ may be formulated into a pharmaceutical composition with a suitable carrier or excipient, and is preferably administered orally, such as in the form of a tablet, capsule, solution, etc. (col.17, l.50-col.18, l.12).
Harada is cited as factual evidence that endometriosis is characterized by dysmenorrhea (specifically, secondary dysmenorrhea), chronic pelvic pain and infertility (col.1, para.3, p.81-col.2, para.1, p.81).
The teachings of Wen et al., as further evidenced by Harada, document the function of PQQ – or its derivative or salt forms, such as PQQ disodium salt – for the treatment or prevention of endometriosis, a disease that is characterized by the presence of both secondary dysmenorrhea and infertility. Such teachings anticipate Applicant’s method defined by instant claims 1, 3 and 5-7.
Claim 2 defines an oral dosage of PQQ that is “about 5 mg/day to about 10 mg/day for preventing of primary dysmenorrhea or secondary dysmenorrhea”.
Wen et al. teaches an adult dose of about 2-20 mg/day for the treatment or prevention of endometriosis, which is characterized by the presence of secondary dysmenorrhea. Such teachings anticipate Applicant’s dosage range of “about 5 mg/day to about 10 mg/day” for prevention of secondary dysmenorrhea, absent any explicit definition of the amount of variation tolerated by the term “about” as used to define the instantly claimed dosage range.
Claim 4 recites various effects of the administration of PQQ to the recited patient.
Here, Wen et al. teaches that the administration of PQQ for the treatment or prevention of endometriosis functions to increase fertility and chances of pregnancy, thereby meeting “at least one” of the benefits recited in instant claim 4.
Claim 5 defines the PQQ derivative as one that is “digestible or metabolizable to [PQQ] in vivo”.
Claim 6 depends from claim 5 and further defines the derivative as one that is “hydrolysable to [PQQ] in digestive tract”.
Claim 7 depends from claim 6 and further defines the derivative as, e.g., “a pharmaceutical or food acceptable salt”.
Wen et al. teaches the administration of PQQ, or derivatives or salts thereof, including PQQ disodium salt.
Claim 8 recites that the PQQ is administered “once a day”.
Wen et al. teaches an adult dose of about 2-20 mg/day for the treatment or prevention of endometriosis, which is necessarily a “once a day” administration on any single day this dosage is administered to the patient.
MPEP §2131.01 states that “[n]ormally, only one reference should be used in making a rejection under 35 U.S.C. 102”, but that it is proper to apply a second reference when the extra reference is cited for the purpose of “show[ing] that a characteristic not disclosed in the reference is inherent”.
Therefore, claims 1-8 are properly anticipated under AIA 35 U.S.C. §102(a)(1).
Conclusion
Rejection of claims 1-8 is proper.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at (571)-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
February 17, 2026