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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed 06/20/2025 has been considered and the references therein are of record.
Claim Objections
Claim 14 is objected to because of the following informalities: contains a grammatical error, reciting "or" twice.
Claim 14 is objected to because of the following informalities: contains an error, reciting ”a metabolic condition" twice.
Appropriate correction is required.
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.
Claim 18 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.
Claim 18 is indefinite in the recitation of the phrase “such as” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP §2173.05(d).
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 1-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Jay et al., 2016 (WO2016123123A1) (see IDS Document or instant PTO-892).
The instant claims are drawn to a method of treating pain, wherein the method comprises administering a pharmaceutically effective amount of PRG4, specifically rhPRG4, to a subject in need thereof. The instant claims are drawn to the pain being joint pain. The instant claims are drawn to the joint pain being associated with various disorders and diseases as listed in instant claim 6.
Jay teaches a method of treating pain by administering rhPRG4, specifically joint pain associated with gout as measured by the Von Frey test, which is a test that determines afferent pain sensitization as a result of joint inflammation by probing the paws of the affected limb with a thin filament wire (Example 7). Jay teaches PRG4 is administered to the subject as a pharmaceutically acceptable composition and that the pharmaceutically acceptable composition comprises a pharmaceutically acceptable carrier or diluent (para[0074]).
Therefore, Jay anticipates that instant claims.
Claim Rejections - 35 USC § 103
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.
Claims 1-6, 13-14, 18, 22, 25, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Jay et al., 2016 (WO2016123123A1) as applied to claims 1-6 above (instant PTO-892).
The instant claims 1-6 are discussed above. The instant claims are also drawn to the pain being inflammatory bowel disease pain, neuropathic pain, inflammatory pain, orofacial pain, migraine pain, cancer pain, ocular neuropathic pain, associated with damaged or dysfunctional corneal nerves, Morton's neuroma pain, or general pain disease. The instant claims are drawn to the subject having Crohn's disease, ulcerative colitis, or interstitial cystitis/bladder pain syndrome (IC/BPS). The instant claims are drawn to the subject having neuropathic pain that is either caused by nerve pressure or nerve damage after surgery or trauma, a viral infection, cancer, a vascular malformation, alcoholism, a neurological condition such as multiple sclerosis, a metabolic condition, hand, foot and mouth disease, or a combination thereof or is caused by a side effect of medication. The instant claims are drawn to the inflammatory pain being acute inflammatory pain or constant. The instant claims are drawn to the orofacial pain being caused by a temporomandibular disorder (TMJD), a trigeminal neuropathic pain disorder, a neurovascular disorder, a complex temporomandibular disorder, burning mouth syndrome, a sleep disorder, orofacial dyskinesia and/or dystonia, trauma, cervicalgia, mucositis, or a combination thereof. The instant claims are drawn to the general pain disease being a chronic pain syndrome. The instant claims are drawn to the chronic pain syndrome being either associated with osteoarthritis, rheumatoid arthritis (RA), back pain, fibromyalgia, inflammatory bowel disease (IBD), surgical trauma, advanced cancer, or a combination thereof, or being chronic pelvic pain or associated with endometriosis. The instant claims are drawn to a method of inhibiting tumor necrosis factor (TNF)-alpha simulated nerve growth factor (NGF), inhibiting transient receptor potential ankyrin 1 (TrpA1) expression, or inhibiting nerve growth factor (NGF)/tropomyosin receptor kinase A (Trk A) binding, by administering PRG4, specifically rhPRG4, to a subject.
The teachings of Jay and how they meet the limitations of claims 1-6 are outlined above in the preceding rejection and are hereby incorporated. Jay teaches that inflammation can cause chronic pain (para[0046]). Jay teaches that “the discovery that PRG4 can be used as an anti-inflammatory agent, for example, to mitigate inflammation when it is excessive, rogue or unwarranted provides promise for treating chronic or acute inflammatory conditions and regulating, reducing or inhibiting the levels of associated inflammation” (para[0046]). Jay teaches that PRG4 can treat a patient suffering from an inflammatory condition, including arthritis, irritable bowel disease, Crohn’s disease, trauma, post-traumatic neuroinflammation, brain injury, neurological diseases, ocular allergic diseases, glaucoma, intra-ocular pressure, and cancer (claims; Examples 5-7; & para[00102]).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Jay. One of ordinary skill in the art would use the teachings of Jay to arrive at the claimed invention because Jay teaches that inflammation can cause chronic pain and PRG4 treats inflammation, and therefore an ordinary artisan would find it obvious that treating inflammation treats chronic pain and rhPRG4 would treat pain. Said another way, an ordinary artisan would have found it obvious from the disclosure of Jay that using rhPRG4 to inhibit inflammation would result in treating pain. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims are obvious over Jay et al.
Claims 1-6, 13-14, 18, 22, 25, 29, 31, 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Jay et al., 2016 (WO2016123123A1) as applied to claims 1-6, 13-14, 18, 22, 25, and 35-36 above (instant PTO-892).
The instant claims 1-6, 13-14, 18, 22, 25, and 35-36 are discussed above. Instant claim 29 is drawn to the pain being ocular neuropathic pain associated with damaged or dysfunctional corneal nerves, or caused by peripheral or centralized sensitization. Instant claim 31 is drawn to the subject that has ocular neuropathic pain also has dry eye. Instant claim 33 is drawn to the pain being Morton's neuroma pain that is associated with a thickening of the tissue around one of the nerves leading to toes.
The teachings of Jay and how they meet the limitations of claims 1-6, 13-14, 18, 22, 25 and 35-36 are outlined above in the preceding rejection and are hereby incorporated. Jay does not explicitly teach the pain being ocular neuropathic pain associated with damaged or dysfunctional corneal nerves, or caused by peripheral or centralized sensitization. Jay does not explicitly teach the subject having ocular neuropathic pain also has dry eye. Jay does not explicitly teach the pain being Morton's neuroma pain that is associated with a thickening of the tissue around one of the nerves leading to toes.
Jay teaches a method of reducing or inhibiting an inflammatory condition by administering rhPRG4, where the inflammatory condition is a neurological disease (para[0081]). Jay teaches that PRG4 is administered to the patient systemically to contact a nerve cell, retinal cell, corneal cell, conjunctival cell, an ocular cell, or an ophthalmic cell to reduce or inhibit inflammation (para[0018-9]). Jay teaches that PRG4 is involved in the lubrication of interfacing tissues such as between the surface of the eye and eyelid (para[0052]).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Jay. One of ordinary skill in the art would use the teachings of Jay to arrive at the claimed invention because Jay teaches that rhPRG4 can treat an inflammatory condition that is a neurological disease and inflammation associated with a nerve cell, retinal cell, corneal cell, conjunctival cell, an ocular cell, and an ophthalmic cell, as well as eye lubrication. An ordinary artisan would find it obvious in view of these teachings that administration of rhPRG4 would treat the specific pains caused by damaged or dysfunctional corneal nerves, dry eye, and/or Morton's neuroma because rhPRG4 treats inflammation, which causes pain, associated with the cell types of each of these diseases. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims are obvious over Jay et al.
Claims 1-6, 13-14, 18, 22, 25, 29, 31, 33, 35-36, and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Jay et al., 2016 (WO2016123123A1) as applied to claims 1-6, 13-14, 18, 22, 25, 29, 31, 33, and 35-36 above (instant PTO-892).
Instant claims 1-6, 13-14, 18, 22, 25, 29, 31, 33, and 35-36 are discussed above. Instant claims 39-42 are drawn to a method of inhibiting tumor necrosis factor (TNF)-a simulated nerve growth factor (NGF), inhibiting transient receptor potential ankyrin 1 (TrpA1) expression, or inhibiting nerve growth factor (NGF)/tropomyosin receptor kinase A (Trk A) binding by administering a pharmaceutically effective amount and composition of rhPRG4 to a subject.
The teachings of Jay and how they meet the limitations of claims 1-6, 13-14, 18, 22, 25, 29, 31, 33, and 35-36 are outlined above in the preceding rejections and are hereby incorporated. Jay teaches that administration of PRG4 inhibitors reduces the production of inflammatory cytokines, including TNF-alpha and growth factors (claims; para[0005,0031 0027, & 0093]).
Jay does not explicitly teach a method of inhibiting tumor necrosis factor (TNF)-alpha simulated nerve growth factor (NGF), inhibiting transient receptor potential ankyrin 1 (TrpA1) expression or inhibiting nerve growth factor (NGF)/tropomyosin receptor kinase A (TrkA) binding by administering a pharmaceutically effective amount and composition of rhPRG4 to a subject.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Jay. One of ordinary skill in the art would use the teachings of Jay to arrive at the claimed invention because Jay teaches that PRG4 inhibits TNF-alpha, which logically follows that NGF that is stimulated by TNF-alpha would also be inhibited. While Jay does not explicitly teach the subsequent mechanism steps following inhibition of TNF-alpha that result in a reduction in inflammation and pain, an ordinary artisan would find it obvious that constituents downstream of TNF-alpha would be inhibited by the inhibition of TNF-alpha. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims are obvious over Jay et al.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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, Jeffrey Stucker can be reached at (571) 272-0911. 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.
/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights