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 .
The amendment filed 15 January 2026 is acknowledged and has been entered.
Response to Arguments
In response to the Double Patenting rejection Applicant asserts that
Claims of the '724 patent are directed to a method of administering a plasma protein fraction to the subject to treat the subject for pain. Certain dependent claims further define the pain as chronic, peripheral, or central, define the plasma fraction as the PPF, and define certain administration regimen.
The Office asserts that treating peripheral neuropathy by administering a Plasma Fraction to the subject would have been obvious over the claims of the '724 patent. In making this rejection, the Office asserts that the pending claims and the claims of the '724 patent are drawn to a method of treating a subject for pain/neuropathy with an effective amount of PPF. The Office also reasons that the instant claims encompass and/or are encompassed by the claims of the '724 patent. (Page 4 of the Office Action.)
As noted above, the claims of the '724 patent are directed to a method of administering a plasma protein fraction to the subject to treat the subject for pain. The Office does not explain how treating peripheral neuropathy would have been obvious over treating pain.
The specification of the '724 patent describes pain and peripheral neuropathy as separate and distinct conditions. For example, from column 25, lines 21 to 55, the '724 patent describes pain as:
1. acute or chronic pain;
2. central pain (neurological conditions caused by damage or dysfunction of the central
nervous system);
3. constant or intermittent pain;
4. pain having moderate or severe intensity;
5. pain with immediate or delayed onset;
6. peripheral pain.
From column 25, lines 52 to 55, the '724 patent states that the invention disclosed therein can be used to treat pain or peripheral neuropathy. The use of the conjunction "or" indicates that the '724 patent lists "pain" and "peripheral neuropathy" as different conditions.
From column 25, line 52 to column 26, line 36, the '724 patent states that the plasma products disclosed therein could be used to treat peripheral neuropathy, which is defined as "conditions involving damage to the peripheral nervous system" (column 25, lines 55-56). The '724 patent identifies several types of peripheral neuropathies from column 26, lines 1 to 27.
A person of ordinary skill in the art would readily recognize that while pain maybe associated with peripheral neuropathy, pain is not always associated with peripheral neuropathy and pain can arise from various conditions other than peripheral neuropathy. In other words, treating pain may involve treating conditions other than treating peripheral neuropathy and, conversely, treating peripheral neuropathy may not involve treating pain. Therefore, treating peripheral neuropathy using a plasma fraction would not have been obvious over treating pain using a plasma fraction.
Based on the foregoing, the Office has failed to establish that, based on the claims of the '724 patent, treating peripheral neuropathy as instantly claimed would have been obvious over treating pain as broadly described in the '724 patent. Therefore, the pending claims are not obvious over the claims of the '724 patent and, accordingly, Applicant respectfully requests reconsideration and withdrawal of the obviousness-type double patenting rejection over the claims of the '724 patent.
Applicant’s argument, that treatment of peripheral pain and treatment of peripheral neuropathy are different and distinct, has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the Applicant’s admission that the treatment of peripheral neuropathy is distinct from treating peripheral pain.
Claim Rejections - 35 USC § 112
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 14-17 and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
In Ariad Pharm. Inc. v. Eli Lily & Co. 598 F ad 1336 (Fed. Cir. 2010) en banc}, the Federal Circuit noted the importance of an application's disclosure, stating, “the hallmark of written description is disclosure.” A disclosure adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1354. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbot Labs, 636 F.3d 1341, 1948 (Fed. Cir. 2011)
Satisfying the written description requirement “varies with the nature and scape of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F. 3d 1349, 1357 (Fed. Cir. 2005). The Federal Circuit explained what is required to meet the written description requirement in Ariad Pharm., Inc. v. Eli Lilly & Co:
The written description of the instant Specification provides thorough discussion of the treatment of wounds and pain by use of the PPF and provides evidence that Applicant was in possession of a treatment method of healing wounds and pain, including peripheral pain. However, as Applicant points out treatment of pain is distinct from treatment of neuropathy, and the Specification does not provide sufficient evidence that Applicant was in possession of an “effective amount” of PPF to treat peripheral neuropathy, other than the pain associated with the neuropathy.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655